Diana Ernst, RPh

The Food and Drug Administration (FDA) has approved the combination of Opdivo (nivolumab; Bristol Myers Squibb) plus Yervoy (ipilimumab; Bristol Myers Squibb) and 2 cycles of platinum-doublet chemotherapy, for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

The FDA has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

The FDA has approved Lynparza® for use in combination with bevacizumab as first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer

The FDA has granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy; Immunomedics) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease.

The FDA has approved Tukysa (tucatinib; Seattle Genetics), in combination with trastuzumab and capecitabine, for treatment of adult patients with advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, including patients with brain metastases, who have received 1 or more prior anti-HER2-based regimens in the metastatic setting.

The approval was based on data from the CASPIAN study, an active-controlled, open-label trial that investigated the combination of durvalumab plus chemotherapy vs chemotherapy alone.

The FDA has approved neratinib (Puma Biotechnology), a kinase inhibitor, in combination with capecitabine, for the treatment of adult patients with advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received 2 or more prior anti-HER2 based regimens in the metastatic setting.

Strontium89 (Strontium Chloride Sr-89 injection), a radiopharmaceutical indicated for the relief of bone pain in patients with painful skeletal metastases, has been made available by Q BioMed.

Lorcaserin may potentially increase the risk of cancer, according to results from a clinical trial assessing the safety of the weight loss agent.

The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.