While last week was eventful with European Society for Medical Oncology (“ESMO”) congress taking place, this week saw the approval of Pfizer Inc.’s (PFE - Free Report) Bavencio in Europe. On the one hand, TESARO, Inc.’s (TSRO - Free Report) Zejula received positive CHMP opinion in the EU, while on the other, Pfizer’s Sutent got a mixed view from an FDA advisory committee for a label expansion application.
In a setback for Roche (RHHBY - Free Report) , two early stage studies on Tecentriq were put on partial hold. A smaller biotech company, Karyopharm Therapeutics Inc. (KPTI - Free Report) announced that its oral selective inhibitor, selinexor, was superior to placebo in reducing risk of progression or death in dedifferentiated liposarcoma patients.
Recap of the Week’s Most Important Stories
TESARO’s Zejula Nears Approval in Europe for Ovarian Cancer: TESARO announced that the Committee for Medicinal Products for Human Use ("CHMP") has recommended marketing approval of Zejula. The company is seeking approval for Zejula as monotherapy for the maintenance treatment of women suffering from recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. The drug was approved in the United States in March. (Read more: TESARO’s Drug Zejula Gets Positive CHMP Opinion)
Pfizer’s Bavencio Approved in Europe; Mixed View on Sutent: Pfizer’s Bavencio received a boost with approval in Europe for treating metastatic Merkel cell carcinoma. With this approval, Bavencio became the first immunotherapy available in Europe for this indication. A launch is expected by October 2017. The drug is already approved in the United States. However, a label expansion application for Sutent as adjuvant treatment for recurrent renal cell carcinoma ("RCC") received a mixed opinion from the FDA advisory committee. A decision from the FDA is expected in January 2018. The drug is currently approved as first-line treatment for RCC. (Read more: Pfizer's Sutent Label Expansion Gets Mixed FDA Committee View)
Disappointment Continues for Roche: After last week’s approval of Amgen’s biosimilar of Roche’s cancer drug, Avastin, the FDA, this week, put a partial hold on two early stage studies on latter’s Tecentriq, which were evaluating the drug in multiple myeloma and follicular lymphoma patients. The partial hold was implemented due to safety issues found in studies evaluating Merck & Co’s (MRK - Free Report) Keytruda in combination with Celgene's Revlimid and Pomalyst in blood cancer. Meanwhile, data announced from the phase III MURANO study conducted by Roche, showed that Venclexta in combination with Rituxan achieved a statistically significant improvement in progression free survival in chronic lymphocytic leukemia patients compared to Teva Pharmaceutical Industries Limited’s (TEVA - Free Report) Treanda plus Rituxan. (Read more: Roche Announces Positive Data on Leukemia Drug)
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