Genentech, a member of the Roche Group, announced completing the submission of a supplemental Biologics License Application, or sBLA, to the FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer, or EBC, with residual disease after neoadjuvant treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
https://thefly.com/landingPageNews.php?id=2858815
Tuesday, February 5, 2019
Sanofi says Isatuximab Phase 3 trial meets primary endpoint
Sanofi announced the pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone. Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year. “We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” said John Reed, Head of Research and Development at Sanofi. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.” Multiple myeloma is the second most common hematologic malignancy[1], with more than 138,0002 new cases worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden. The randomized, multi-center, open label Phase 3 study, known as ICARIA-MM, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24 countries. All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment. The safety profile was evaluated as a secondary endpoint.
https://thefly.com/landingPageNews.php?id=2858817
https://thefly.com/landingPageNews.php?id=2858817
Haemonetics backs FY19 adj. EPS view of $2.25-$2.35, consensus $2.33
Backs FY19 revenue guidance of up 6%-8%. Raises FY19 cash flow from operating activities guidance to $160M-$185M from $150M-$175M.
https://thefly.com/landingPageNews.php?id=2858851
https://thefly.com/landingPageNews.php?id=2858851
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