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.

The U.S. Food and Drug Administration approved cabozantinib (Cabometyz; Exelixis) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read full press release.

The U.S. Food and Drug Administration approved gilteritinib (Xospata; Astellas) for treatment of adult patients who have relapsed or refractory acut myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA approved test. Read full press release.

The U.S. Food and Drug Administration approved atezolizumab (Tecentriq; Genentech) in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. Read full press release.

The U.S. Food and Drug Administration approved romiplostim (Nplate; Amgen) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda; Merck) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Read full press release.