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Sunday, June 3, 2018

#ASCO18: Maintenance Therapy Changes Paradigm in Rare Childhood Sarcoma


Practice-changing findings were reported for pediatric rhabdomyosarcoma at the 2018 ASCO Annual Meeting Sunday. Investigators said a course of low-dose maintenance chemotherapy administered after standard-of-care intensive chemotherapy led to significant improvements in disease-free (DFS) and overall survival (OS).
The findings from the decade-long trial were hailed as 1 of the 4 most important clinical developments to emerge from the 5800 abstract presentations at the ASCO meeting.
Patients receiving maintenance therapy had a 5-year DFS advantage of 77.6% versus 69.8% in the standard arm (HR = 0.68; 95% CI, 0.45-1.02; P = .0613). Low-dose maintenance therapy following initial treatment increased the 5-year OS from 73.7% to 86.5% in pediatric cases (HR = 0.52; 95% CI, 0.32-0.86; P = .0111).1,2
“At the end of this long, but not easy, study, we concluded that maintenance is an effective and well-tolerated treatment for children with high risk rhabdomyosarcoma and our group decided this is the new standard treatment for patients—at least, in Europe we will keep standard intensive chemotherapy and then we’ll continue with 6 more months of low-dose chemotherapy,” said lead study author Gianni Bisogno, MD, PhD, a professor at the University Hospital of Padova in Italy and Chair of the European Pediatric Soft Tissue Sarcoma Study Group (EpSSG).
Bisogno added that this maintenance approach can potentially be applied to other pediatric tumors.
The standard intensive therapy course is a 6- to 8-month regimen that includes 9 cycles of high-dose chemotherapy, radiotherapy, and surgery. Patients up to the age of 21 with no evidence of metastasis were enrolled in the study following standard treatment, and were randomized to either stop treatment or continue with maintenance therapy for 6 additional months. Treatment in the experimental arm included 6 cycles of intravenous vinorelbine at 25 mg/m2 on days 1, 8, and 15 of each 28-day cycle; and continuous daily oral cyclophosphamide at 25 mg/m2. Standard treatment included 9 cycles of ifosfamide, vincristine, and actinomycin D, plus or minus doxorubicin, surgery, and/or radiotherapy.
Those enrolled were considered at high risk of recurrence due to having large tumors in hard-to-treat locations. After completing standard treatment, 371 patients aged 6 months to 21 years (79% 10 years or younger) were randomized to standard (n = 186) or maintenance care (n = 185).
In addition to prolonged survival rates, there were no cardiac, hepatic, gastrointestinal, or renal toxicities. “Treatment toxicities were much lower in comparison with what we usually see with standard chemotherapy,” Bisogno said. ‘We have less anemia, less neutropenia, less thrombocytopenia. We had fewer episodes of infection and we didn’t see any important organ dysfunction.”
Low blood cell counts were the most common adverse event in the maintenance arm, although generally mild. Febrile neutropenia occurred in 25% of patients, and infections were lower in the maintenance arm (29.4%) than what is generally seen with standard therapy. Grade 4 neurotoxicity occurred in 1.1% of patients.
Grade 3/4 hematological toxicities in the maintenance arm included neutropenia (80.6%), leukopenia (73.9%), anemia (8.9%), and low platelet counts (0.6%).
Rhabdomyosarcoma is a rare soft tissue cancer that is diagnosed in 350 children in the United states and 320 in the European Union each year; 40% of all rhabdomyosarcoma diagnoses occur in adults. Modern treatment enables the cure of 70% to 80% of children, and children who are alive at 5 years are considered cured, as recurrence is low.
However, standard of care in this disease has not changed in 30 years, Bisogno said.
“At the end of standard treatment more than 90% of children have no evidence of tumor, but we know that after 1 year or 2 years, one-third of these children relapse and most of them die,” Bisogno said, explaining the decision to initiate the trial of maintenance therapy.
ASCO expert Warren Chow, MD, a specialist in the treatment of sarcomas, described the EpSSG study as a model for how to conduct large and important trials in rare diseases. The trial took 10 years to complete partly because of the rarity of the disease and the challenges in reaching the enrollment goal.
Because there are slight differences in the way rhabdomyosarcoma is treated in the United States, there will need to be further tests with US protocols before these new findings become standard of care, Chow said. Also, it will need to be determined whether these results are applicable to patients older than 21 years of age, he said. “Even with these caveats, this is the most significant treatment advance in this disease in more than 30 years.”

References

  1. Bisogno G, Luca De Salvo G, Bergeron C, et al. Maintenance low-dose chemotherapy in patients with high-risk (HR) rhabdomyosarcoma (RMS): A report from the European Paediatric Soft Tissue Sarcoma Study Group (EpSSG). J Clin Oncol. 2018;36(suppl;abstr LBA2).
  2. Maintenance Chemotherapy Extends Life for Children With a Rare Cancer – First Treatment Advance for This Cancer in 30 Years [press release]. Alexandria, VA: ASCO; June 3, 2018. https://www.asco.org/about-asco/press-center/news-releases/maintenance-chemotherapy-extends-life-children-rare-cancer?et_cid=40339664&et_rid=513052853&linkid=Read+more
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#ASCO18: Agios med induces deep remission in leukemia in Phase 1


Single-agent ivosidenib was well tolerated and resulted in deep and durable remissions in patients with relapsed or refractory acute myeloma leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation, according to a researcher here.
The rate of complete remission (CR) or CR with partial hematologic recovery (CRh) was 30.4% in these patients (95% CI, 22.5-39.3), reported Daniel Pollyea, MD, of the University of Colorado School of Medicine in Aurora, at the American Society of Clinical Oncology (ASCO) annual meeting.
“In this population of IDH-positive relapsed/refractory AML patients, ivosidenib was able to achieve durable responses,” said Pollyea.
The true CR rate with ivosidenib (formerly AG-120) was 21.6%, with a median duration of response of 9.3 months (95% CI, 5.6-18.3) and median overall survival (OS) of 18.8 months in these patients.
In all, 41.6% of patients responded (95% CI, 32.9-50.8), with a 6.5-month median duration of response (95% CI, 4.6-9.3), according to the study, which was published simultaneously in the New England Journal of Medicine.
“In addition, patients were able to achieve transfusion independence,” Pollyea said. Among 84 patients dependent on either red-cell or platelet transfusions (or both) at the start of treatment, 35% attained transfusion independence — and fewer infectious complications were seen in these patients.
Daniel Pollyea, MD
Daniel Pollyea, MD, presenting the results
Of the 41 patients who were transfusion-independent at the start of treatment, more than half were able to maintain this for 56 days or more while on treatment.
In February 2018, the FDA accepted a New Drug Application (NDA), along with priority review, for ivosidenib for the treatment of patients with relapsed or refractory AML with IDH1 mutation. The agency is expected to make their decision later this year.
Following similar phase I data last year, the FDA approved the oral IDH2 inhibitor enasidenib (Idhifa) for relapsed or refractory AML patients with IDH2 mutations.
ASCO discussant Eunice Wang, MD, of Roswell Park Comprehensive Cancer Center in Buffalo, New York, described ivosidenib as a “companion drug” for patients with IDH1-mutations.
IDH1 mutations are more rare than IDH2 mutations, occurring in roughly 6%-10% of AML patients compared with 9%-13%.
Wang told MedPage Today that like enasidenib for IDH2-mutant AML, ivosidenib will likely become the next standard of care in IDH1-mutant AML. “I can’t imagine the FDA would not approve the drug given the similarity of the data,” she said, adding that AML patients will need to routinely be tested for IDH1/IDH2 mutations.
“I am hopeful that we’ll have approval of AG-120, or ivosidenib, before the summer is out,” said study co-author Courtney DiNardo, of MD Anderson Cancer Center in Houston.
In the clinic, DiNardo told MedPage Today that she has seen “dramatic” responses to the drug firsthand, noting two patients she treated on the study who had durable responses of 1 to 2 years.
But Wang highlighted that more work needs to be done, citing the need for markers of resistance, whether they be co-mutations or otherwise. The study tested for the variant allele frequency of IDH1 mutations, and in 21% of CR/CRh patients, no residual IDH1mutations were detectable on digital polymerase-chain-reaction assay. “So the drug is working, but we’re not seeing massive eradication of that molecular marker,” she said.
Eunice Wang, MD
Eunice Wang, MD, discussing the results
The next generation of IDH1 inhibitors, some of which are already undergoing dose-escalation studies, may be the solution to move treatment forward for these patients, Wang said.
The current study looked at data on 179 patients with relapsed and refractory IDH1-mutant AML who were part of a phase I dose-escalation and dose-expansion trial. Median patient age was 67. Evaluable patients (n=125) included those with relapsed or refractory disease who were treated with a 500-mg daily dose and had 6 months of follow-up. Most patients had primary AML (66%).
With a median follow-up of nearly 15 months, the median OS was 8.8 months in all comers, and 9.3 months for responders that did not achieve CR/CRh.
Overall 25.6% patients had a grade 3 or higher treatment-related adverse event, the most common of which were prolongation of the QT interval (7.0%), IDH differentiation syndrome (4.7%), anemia (2.3%), and thrombocytopenia (1.9%). Diarrhea, decreased platelet counts, hypoxia, febrile neutropenia, and leukocytosis each occurred in 1.2% of patients.
DiNardo highlighted IDH differentiation syndrome as a side effect to be aware of, but this can successfully be treated with steroids when found early, she said.
Ivosidenib and enasidenib are both currently being tested in the frontline setting with ‘7+3’ chemotherapy for IDH1/IDH2-positive AML, and promising results were presented at the 2017 American Society of Hematology annual meeting.
The study was funded by Agios Pharmaceuticals. S several co-authors are company employees.
Pollyea, DiNardo and co-authors disclosed multiple relevantrelationships with industry including Agios, Bayer, Celgene, Pfizer, Novartis, Servier, Pierre Fabre, Amgen, Incyte, Jazz, Daiichi Sankyo, ImmunoGen, MacroGenics, Ono, Seattle Genetics, Sunesis, GlycoMimetics.
Wang disclosed relevant relationships with Abbvie, Amgen, Arog, ImmunoGen, Pfizer, Spectrum, Incyte, Jazz Pharmaceuticals, and Novartis.
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#ASCO18: Evidence Grows for Colon Cancer Occurrence in Younger People


The recent observation of an increasing incidence of colorectal cancer among younger people in the U.S. is also being seen in other developed countries, which has implications for screening recommendations, a researcher reported here.
In the U.S., the annual percent change in colon cancer for individuals age <55 between 1988 and 2007 was +3.08% (95% CI 2.61-3.56), compared with an annual percentage change of -4.20 (95% CI -5.11 to -3.28) for those ages ≥55, according to Rashid Lui, MD, of the Chinese University of Hong Kong.
And for rectal cancer in the U.S., the annual percent change for those <55 was +3.30% (95% CI 2.41-4.20) compared with a change of -3.35% (95% CI -3.82 to -2.87) for those >55, Lui said in a presentation at Digestive Disease Week.
“As we all know, the risk of colorectal cancer increases with age, and the incidence really starts to kick off at around 50 years of age, so most screening programs have recommended starting screening at that time point,” Lui said.
A recent report from the American Cancer Society noted that the incidence of colon cancer increased by 1% to 2.4% annually since the mid 1980s in individuals ages 20 to 39, and by 0.5% to 1.3% since the 1990s among those ages 40 to 54, whereas the incidence in those >55 has been declining since the 1980s.
This led the society to issue a recommendation just this week that screening begin at age 45 for individuals at average risk. This recommendation also was endorsed by the American Gastroenterological Association.
“These observations also raise the question as to whether the increasing trend among younger adults is limited to the U.S., or whether it is an emerging global problem,” Lui said.
Of particular concern is that some studies have suggested that in younger patients, colorectal cancer can present at more advanced stages or even with metastases, he said.
To explore these temporal trends in incidence, Lui’s group extracted data from the International Agency for Research on Cancer, analyzing data from six jurisdictions that have collected complete data since 1988: the U.S., the U.K., Sweden, Japan, China (Shanghai and Hong Kong).
From a total population of 113,643,145 individuals, there were 65,909 incident cases of young-onset colorectal cancer as of 2007.
The “young-shift” in colorectal cancer seen in the U.S. was also observed elsewhere. For instance, the annual percent change for rectal cancer in Sweden was +1.26% (95% CI 0.67-1.85) for patients <55 compared with -0.33% (95% CI -0.63 to -0.02) for those >55, and change in colon cancer rates in Hong Kong were +1.65% (95% CI 0.93-2.38) for younger individuals and -1.29 % (95% CI -2.44 to -0.14) for those who were older.
In other areas, there also has been an increase in rates among the younger population without a decline in incidence among older individuals. This pattern was seen for colon cancer in Sweden and Shanghai, and for rectal cancer in the U.K., Hong Kong, and Shanghai.
“This study suggests that earlier colorectal screening should be considered,” he concluded, adding that his group plans further work investigating trends in colorectal cancer in developing nations.
Limitations of the study included its cross-sectional design and relative short 20-year follow-up.
Obesity and Colon Ca
In a separate presentation, Po-Hong Liu, MD, of Massachusetts General Hospital in Boston, explored the potential role of obesity in the “alarming” trends of colorectal cancer in younger patients.
Using data on height, weight, lifestyle, dietary factors, and medications from the Nurses’ Health Study II and cancer cases from medical record reviews and the National Death Index, Liu’s group identified 121 incident cases of colorectal cancer since 1989 among women age <50, during 1,431,510 person-years of follow-up.
For those whose BMI was ≥30, defined as obese, the multivariate hazard ratio for young-onset colorectal cancer was 1.92 (95% CI 1.08-3.44) compared with those whose BMI was normal. The risk also was consistent among those with a family history of the disease and for those who had not undergone colonoscopy within the previous 10 years.
Further analysis determined that obesity was significantly associated with colon cancer (HR 2.07, 95% CI 1.02-4.20), and nonsignificantly associated with rectal cancer (HR 1.59, 95% CI 0.55-4.60).
Change in weight since adolescence also was associated with an increased risk. Compared with women who had maintained their weight within 5 kg (about 2.2 lbs) since age 18, those who had gained ≥40 kg also had an increase risk of early-onset colorectal cancer (HR 1.96, 95% CI 0.92-4.19).
“Obesity may play a significant role in the pathogenesis of early onset colorectal cancer, through many possible mechanisms such as changes in the microbiota and increases in adipokines,” she said.
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#ASCO18: Genetic Test Can Rule Out Chemo Use in Early Breast Cancer


About 70% of women with the most common form of early breast cancer don’t need chemotherapy after surgery, a researcher said.
The finding from a randomized clinical trial suggests a change in clinical practice for majority of women with disease that is hormone receptor-positive, HER2-negative, and axillary node-negative, according to Joseph Sparano, MD, of Albert Einstein Cancer Center and Montefiore Health System in New York City.
After surgery, most of those women are usually treated with hormone therapy and chemotherapy, Sparano told reporters here at the American Society of Clinical Oncology (ASCO) annual meeting. The results were also published in the New England Journal of Medicine.
But if they have a low or mid-range score on a genetic test for the risk of recurrence — as did about 70% of women in the study — chemotherapy appears to have no detectable effect on the danger of the cancer returning, Sparano said.
In clinical practice, he said, “application of this test would be expected to spare chemotherapy in about 70% of women and select chemotherapy in about 30%.”
The presentation and publication of the data marks an “extraordinary day” for doctors and patients, commented ASCO expert Harold Burstein, MD, PhD, of Dana-Farber Cancer Center in Boston.
“It allows us to individualize treatment based on extraordinary science that now has tremendous prospective validation,” he said. “The most challenging decisions we make with these patients is whether or not to recommend chemotherapy with all its side effects and its potential benefits.”
Now, the “vast majority of women who have this test performed on their tumor can be told they don’t need chemotherapy, and that can be said with tremendous confidence and reassurance,” Burstein stated.
He noted that the gene test (Oncotype DX Breast Recurrence Score) has been in use for more than a decade, based on data that suggested it was prognostic at the high and low ends. But that data was based on older chemotherapy and hormone therapies, and it was not clear how well it applied to modern treatments.
The study validates the gene test in the modern era and also clears up a “gray zone” — how to treat women with scores that were not clearly prognostic, Burstein said.
TAILORx (Trial Assigning IndividuaLized Options for Treatment) enrolled 10,273 women for what Sparano called the “largest adjuvant breast cancer trial ever performed.”
It was aimed at “threading the needle,” he said: Defining which women were being over- or undertreated.
On the gene test, whose possible scores range from 0 to 100, 1,629 women had tumors with a low score of ≤10 were given endocrine therapy alone, he reported. Another 1,389 had scores of ≥26 and were treated with chemotherapy in addition to endocrine therapy. Standard regimens were used, he said.
The investigators randomized the remaining 6,711 women, with scores from 11 through 25, to get endocrine therapy alone or combined treatment. The primary endpoint of the study was invasive disease-free survival — defined as invasive disease recurrence, second primary cancer, or death — measured on a non-inferiority basis.
The 9-year rates were almost identical — 83.3% for those on endocrine therapy alone and 84.3% for those on combined treatment. The rates yielded a non-significant hazard ratio of 1.08, and the study met the non-inferiority criterion.
Other endpoints, such as distant recurrences and overall survival, were also similar, Sparano said.
However, an exploratory analysis suggested, however, that some women with midrange scores might still benefit from the addition of chemotherapy, Sparano said. Specifically, those ages ≤50 with a recurrence score from 16 through 25 appeared to have fewer distant recurrences if they had combined treatment.
But overall, three groups of women appear to be able to dispense with chemotherapy:
  • Those of any age with a recurrence score of ≤10
  • Those age >50 with a score from 11 through 25
  • Those ≤50 with a score from 11 through 15
The TAILORx results by comes just a few months after a study showing that another test — the PAM50 gene signature — could be used to help decide which patients with early breast cancer should get adjuvant chemotherapy.
The study was supported by the National Cancer Institute, the American College of Surgeons, Cancer and Leukemia Group B, NSABP Foundation, NCIC Clinical Trials Group, North Central Cancer Treatment Group, and Southwest Oncology Group.
Sparano disclosed relevant relationships with Metastat, AstraZeneca, Celgene, Celldex, Genentech/Roche, Juno Therapeutics, Eli Lilly, Merrimack, Novartis, Pfizer, and Prescient Therapeutics. Co-authors disclosed multiple relevant relationships with industry.
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#ASCO18: Novartis makes a case for earlier Kisqali use in breast cancer


Novartis’ breast cancer drug Kisqali so far hasn’t lived up to expectations, and the drugmaker’s hoping some strong new data in metastatic patients will help. Can the numbers actually boost the drug’s sales? Depends on how doctors decide to use them.
Novartis unveiled the results Sunday at the American Society of Clinical Oncology annual meeting, showing that among patients with HR-positive, HER2-negative breast cancer, adding Kisqali to fulvestrant kept the disease at bay for nearly eight months longer than fulvestrant alone.
That’s “among the biggest improvements since the induction of hormonal therapy some 45 years ago,” study investigator Dennis Slamon, M.D., Ph.D., said.
The results covered women who hadn’t been treated before and those whose disease had progressed after one line of treatment.

In previously untreated patients, the Kisqali-fulvestrant combo staved off disease for a median 20.5 months, compared with just 12.8 months for solo fulvestrant. And investigators estimated that nearly 70% of women in that first-line subgroup still hadn’t seen their disease progress at a median follow-up of 16.5 months.
Up to this point, “the dogma has been that these patients should receive hormonal therapy first, and then if they progress on that, then you give the combination,” Slamon said. Now, though, these data set “a new potential standard for patients that have not seen prior hormonal therapy,” he said.
Whether Kisqali’s performance in this trial translates to earlier use in the real world, though, remains to be seen.
“I’d like to tell you I think it’s going to be used a lot more given these data, but just given what I’ve seen in the past, it’s going to be interesting” to see how prescribing patterns play out, Slamon said. He pointed to Roche blockbuster Herceptin, which physicians—“who tend to be quite conservative in their approach”—continued to hold back until after further lines of chemo, even after data rolled out supporting its first-line use.

Novartis, for one, is hoping to see doctors run with the new data—and bolster Kisqali’s sales in the process. While its rival drug Ibrance, a Pfizer blockbuster, had a big head start on its in-class rivals, analysts still predicted that Kisqali and Eli Lilly player Verzenio could crack the $1 billion mark at their respective sales peaks. So far, though, Kisqali has failed to gain major traction—so much so that CEO Vas Narasimhan, before stepping into the company’s top spot, included jump-starting the product on his list of the top three challenges he’d face as helmsman.
Meanwhile, positive new breast cancer data on Ibrance and Verzenio have continued to boost the profile of the CDK 4/6 class as a whole—and, in turn, expand sales prospects for all three players. “I think it’s been remarkable, since we initially did the first studies, how consistent the data have been across all members of the class,” Slamon said, adding that the results the class has put up so far show that “this is an important new therapeutic approach.”
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#ASCO18: Celldex, Bristol update on immunooncology Phase 1/2 studies


Celldex Therapeutics (CLDX) presented two programs at the 2018 American Society of Clinical Oncology Annual Meeting. Data from the Phase 1/2 study of Celldex’s varlilumab, a CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb’s (BMY) Opdivo, or nivolumab, an anti-PD1 immunotherapy, for patients with ovarian cancer and colorectal cancer, were presented. In addition, an overview of the Phase 2 study of the anti-ErbB3 antibody CDX-3379 in combination with Erbitux in advanced head and neck squamous cell cancer was presented in a “clinical trials in progress” poster session. Varlilumab was featured in an oral presentation that highlighted the ongoing Phase 2 study of varlilumab in combination with Opdivo. The Phase 1/2 study includes cohorts in ovarian cancer, colorectal cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, with data from ovarian cancer and colorectal cancer patients included in the presentation. The majority of patients enrolled in the study had baseline tumors that were mostly “cold” with low expectation of responding to checkpoint inhibition therapy. The combination was well tolerated at all varlilumab dose levels tested. One patient with PD-L1 negative, MSI-high disease experienced a confirmed partial response in the Phase 2 study portion and continues on treatment. Of note, a patient with PD-L1 negative disease, initially considered MMR proficient as determined by standard screening laboratory analysis, achieved a near complete response in the Phase 1 portion of the study, which now continues at 35 months. As part of this study, an additional molecular analysis was conducted on this patient’s tumor. The tumor had a high mutational burden and mutations in genes regulating DNA repair, which together likely contributed to the response. DCR was 20%. CDX-3379 was featured in a “clinical trials in progress” poster presentation that highlighted the ongoing Phase 2 study of CDX-3379, a human monoclonal antibody designed to block the activity of ErbB3, in combination with Erbitux in patients with human papillomavirus negative, Erbitux-resistant, advanced head and neck squamous cell carcinoma. The proposed mechanism of action for CDX-3379 sets it apart from other drugs in development in this class due to its ability to block both ligand-independent and ligand-dependent ErbB3 signaling by binding to a unique epitope. It has a favorable pharmacologic profile, including a longer half-life and slower clearance relative to other drug candidates in this class. The multicenter, open-label, Simon two-stage design study is expected to enroll approximately 27 patients. The primary objective of the study is objective response rate. Secondary objectives include assessments of clinical benefit response, duration of response, progression-free survival and overall survival, and safety and pharmacokinetics associated with the combination. Four clinical trial sites are currently open to enrollment, and Celldex is targeting to complete enrollment to the first stage of the study by the end of the third quarter of 2018. The company continues to explore potential other opportunities in additional indications where ErbB3 is believed to play a role.
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AstraZeneca, MedImmune meet primary endpoints in Phase 3 leukemia trial


AstraZeneca and MedImmune, its global biologics research and development arm, presented results from the Phase III ‘1053’ clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukemia who had received at least two prior lines of therapy. Moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin, showed a 75% objective response rate, a 41% complete response rate, and a 30% durable CR rate. The majority of patients with a complete response had a durable response and achieved a negative minimal residual disease status. The primary endpoint of the trial was durable CR, which is defined as CR with HR for greater than180 days. The median time to HR was 1 month. The most frequent treatment-related adverse events were nausea, peripheral edema, headache, and pyrexia; 8% had infections and 3% had neutropenia deemed treatment-related. Three patient deaths occurred, none of which were determined to be treatment-related. Treatment-related AEs leading to discontinuation were hemolytic uremic syndrome, capillary leak syndrome, and increased blood creatinine. Seven patients had CLS and seven had HUS; this includes four patients who had both CLS and HUS. CLS and HUS were manageable and reversible. In April 2018, AstraZeneca announced that the Food and Drug Administration accepted the Biologics License Application for moxetumomab pasudotox for the treatment of adult patients with HCL who have received at least two prior lines of therapy. The BLA is based on results from the Phase III ‘1053’ clinical trial. The FDA has granted Priority Review status with a Prescription Drug User Fee Act action date set for the third quarter of 2018.
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