FDA Approvals, News & Updates

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).

On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin.

On March 18, 2019, atezolizumab (Tecentriq; Genentech) received a new indication for use with carboplatin and etoposide chemotherapy as first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC).

On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC.

On February 28, 2019, the FDA approved a combination of the HER2/neu receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the adjuvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality an­thracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. This SC injection is a new formulation of intravenous (IV) trastuzumab.

On February 22, 2019, the FDA approved a new indication for trifluridine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoropyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/neu-targeted therapy. The FDA used its priority review process for this new indication and granted it an orphan drug designation. Trifluridine plus tipiracil was previously approved for metastatic colorectal cancer.

On February 15, 2019, the FDA approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with melanoma and involvement of lymph node(s) after a complete resection. This is the second melanoma-related indication for pembrolizumab, which was previously approved by the FDA for the treatment of patients with unresectable or metastatic melanoma.

On January 31, 2019, the FDA approved the combination of pemetrexed (Alimta; Eli Lilly) plus pembrolizumab (Keytruda; Merck) and platinum-based chemotherapy for first-line treatment of patients with metastatic nonsquamous non–small-cell lung cancer (NSCLC) and no EGFR or ALK mutations.

On January 28, 2019, the FDA approved the combination of the oral Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica; Pharmacyclics), plus the CD20-directed cytolytic antibody obinutuzumab (Gazyva; Genentech), for the treatment of adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Imbruvica was already approved as a single agent for different indications, including for adults with CLL or SLL, with or without 17p deletion.

On January 14, 2019, the FDA approved a new indication for cabozantinib (Cabometyx; Exelixis), an oral multitargeted tyrosine kinase inhibitor, for the treatment of patients with hepatocellular carcinoma who had previously received treatment with sorafenib (Nexavar).