12.01.15
FDA Approves Roche’s Cotellic in Advanced Melanoma
Roche received approval from the FDA for Cotellic (cobimetinib) for the treatment of people with BRAF V600E or V600K advanced melanoma in combination with Zelboraf (vemurafenib). Phase III results show Cotellic plus Zelboraf reduced the risk of disease worsening or death (progression-free survival; PFS) by about half (95%), with a median PFS of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone.
Merck KGaA, Pfizer’s Avelumab Gains Breakthrough Status
Merck KGaA and Pfizer received Breakthrough Therapy designation for avelumab for patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody.
Janssen Biotech’s DARZALEX Approved in MM
Janssen Biotech received FDA approval of DARZALEX (daratumumab) injection for in
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