Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Tecentriq, in combination with Avastin, paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer. In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future. The CHMP recommendation is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin, paclitaxel and carboplatin helped people live significantly longer, compared with Avastin and chemotherapy in the intention-to-treat population. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.
Friday, February 1, 2019
Pfizer Receives Positive CHMP Opinion for Lung Cancer Med
Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. The CHMP’s opinion will now be reviewed by the European Commission (EC).
Vizimpro was approved by the U.S. Food and Drug Administration (FDA) in 2018 for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. It was also recently approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC.
“Patients with EGFR-mutated non-small cell lung cancer, a disease that is associated with low overall survival rates, are in need of more treatment options. This positive CHMP opinion is an important step toward bringing this treatment to patients in Europe as a potential new first-line treatment option,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Vizimpro’s development is a direct result of Pfizer’s focus on precision drug development to create tailored options that improve patient outcomes.”
The Marketing Authorization Application (MAA) for Vizimpro was based on results from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase 3 study conducted in patients with locally advanced unresectable, or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225).
Teva Gets Positive Euro Panel Opinion for AJOVY for Migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorization for AJOVY® (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. If approved by the European Commission (EC), AJOVY, a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, will be the first and only anti-CGRP treatment in the European Union (EU) with both quarterly and monthly dosing options.
Migraine is a disabling neurological disease often accompanied by nausea, vomiting, photophobia, phonophobia and changes in vision.1 Globally, there are approximately one billion people affected by migraine2, with more than 50 million people suffering from the disease across Europe.3 It is estimated that the total annual cost of migraine in Europe is €111 billion.4
“We are very pleased to report a positive opinion by the CHMP,” said Richard Daniell, Executive Vice President, European Commercial at Teva. “This is another important milestone for us and the migraine community as a whole. We hope to expand the availability of AJOVY to the EU so that eligible patients can potentially benefit from the flexibility AJOVY offers through quarterly and monthly dosing options.”
Aveo Pharmaceuticals downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth downgraded Aveo Pharmaceuticals to Neutral and cut his price target for the shares to $1 from $9. The company yesterday announced that the FDA has recommended against the filing of tivozanib new drug application, citing the drug’s potential detriment to overall survival seen in the results of the TIVO-3 study, Ramakanth tells investors in a research note. This development adds “significant uncertainty” to the future of tivozanib in the U.S. as a monotherapy, says the analyst.
https://thefly.com/landingPageNews.php?id=2857535
https://thefly.com/landingPageNews.php?id=2857535
Amicus shares undervalued, offer long-term entry point, says JPMorgan
JPMorgan analyst Anupam Rama believes shares of Amicus Therapeutics are undervalued and that current levels provide an attractive long-term entry point. He raised his price target for the stock to $19 from $18 and keeps an Overweight rating on the name. The company is trading slightly above Galafold’s standalone value, which implies that minimal credit is currently being ascribed to its Pompe program and gene therapy initiatives, Rama tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2857547
https://thefly.com/landingPageNews.php?id=2857547
Baxter price target raised to $80 from $72 at Piper Jaffray
Piper Jaffray analyst Matt O’Brien raised his price target for Baxter International to $80 after the company’s Q4 results topped expectations on both the top- and bottom-lines. The primary drivers of the revenue beat in the quarter were the company’s Renal Care, Pharma, Advanced Surgery and Acute Therapies, O’Brien tells investors in a research note. Further, he believes Baxter’s domestic Medication Delivery and Nutrition businesses stabilized during the quarter “with progress made towards restoring demand to pre-hurricane levels.” The analyst remains constructive on the stock and reiterates an Overweight rating.
https://thefly.com/landingPageNews.php?id=2857405
https://thefly.com/landingPageNews.php?id=2857405
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