Filings Update

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 intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, or who are double-refractory to a PI and an immunomodulatory agent. The Phase II MMY2002 study showed an overall response rate of 29.2% (95%) in patients who received a median of five prior lines of therapy, including a PI and an immunomodulatory agent.
 
BMS’ Opdivo Gains Priority Review in RCC
Bristol-Myers Squibb’s sBLA for Opdivo has been accepted for filing and granted priority review by the FDA for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The submission is based on a Phase III study that evaluated the overall survival in patients with previously treated advanced RCC versus everolimus, a current standard of care. The trial was stopped because an assessment concluded that the study met its primary endpoint of overall survival.
 
Advaxis’ ADXS-HER2 Receives EU Orphan Status
Advaxis, Inc. was granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma by the European Medicines Agency (EMA). ADXS-HER2 is an Lm Technology immunotherapy candidate targeting HER2 expressing cancers. Advaxis has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma.

Janssen Submits STELARA for Crohn’s Disease
Janssen Biotech has submitted a BLA to the FDA and a Variation/Extension Application to the EMA seeking approval of STELARA (ustekinumab) for the treatment of moderate to severe Crohn’s disease. The submission includes data from the Phase III UNITI program evaluating the efficacy and safety of STELARA in patients with moderately to severely active Crohn’s disease.