The U.S. Food and Drug Administration approved venetoclax (Venclexta; AbbVie and Genentech) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read full press release. 

The U.S. Food and Drug Administration approved ramucirumab (Cyramza; Lilly) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP of  ≥ 400 ng/mL and have been previously treated with sorafenib. Read full press release.

The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Read full press release. 

FDA granted accelerated approval to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Read full press release.

The U.S. Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test. Read full press release.

The Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Read full press release.

The U.S. Food and Drug Administration approved atezolizumab (Tecentriq; Genentech) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Read full press release. 

The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Read full press release. 

The U.S. Food and Drug Administration approved the expanded use of ibrutinib (imbruvica; Pharmacyclics) in combination with obinutuzumab for adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia (CLL/SLL). Read full press release.