The U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatmetn with fluoropyrimidine, oxaliplatin, and irinotecan. Read full press release.

The U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celegene) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydropgenase-2 (IDH2) mutation as detected by an FDA-approved test. Read full press release.

The U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (Tafinlar and Mekinist, Novartis) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. Read full press release.

The U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Read full press release. 

The U.S. Food and Drug Administration granted regular approval to ceritinib (Zykadia) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, miicrosatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Read full press release. 

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

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

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). Read full press release.

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