The U.S. Food and Drug Administration expanded the indications of regorafenib (Stivarga) to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read full press release.

The U.S. Food and Drug Administration approved atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Read full press release.

The U.S. Food and Drug Administration granted regular approval to osimertinib (Tagrisso) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Read full press release.

The U.S. Food and Drug Administration (FDA) has approved lenalidomide (Revlimid) as maintenance therapy for multiple myeloma (MM) patients after autologous hematopietic stem cell transplantation (auto-HSCT). Read full press release. 

The U.S. Food and Drug Administration approved pembrolizumab (Keytruda) for adult and pediatric patients with classical hodgkin lymphoma (cHL) refractory to treatment, or who have relapsed after three or more prior lines of therapy. Read the full press release.

The U.S. Food and Drug Administration approved lenalidomide (Revlimid) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. Read the full press release. 

The U.S. Food and Drug Administration granted accelerated approved to nivolumab (Opdivo) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months or neoadjuvant or adjuvant treatment with a platinum containing chemotherapy. Read full press release.

South San Francisco, CA -- December 6, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy. Read full press release. 

U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Read more. 

U. S. Food and Drug Administration approved nivolumab (OPDIVO Injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Read more.