Articles

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).

San Francisco, CA—Tumor expression of PD-L1 has consistently predicted ­response and survival outcomes in non–small-cell lung cancer (NSCLC), whereas the role of PD-L1 in immune cells is unclear, said Edward B. Garon, MD, Director, Thoracic Oncology Program, David Geffen School of Medicine, University of California, Los Angeles, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium.

San Francisco, CA—Many patients with leukemia or lymphoma who receive treatment with anti-CD19 chimeric antigen receptor (CAR) T-cell therapy achieve minimum residual disease (MRD) negativity, and many are in complete remission well beyond 12 months.

San Antonio, TX—Adding the PD-L1 inhibitor atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) chemother­apy is the first immunotherapy-based combination to improve progression-free survival (PFS) and overall survival (OS) in women with advanced or metastatic triple-negative breast cancer and PD-L1 expression compared with placebo plus nab-paclitaxel, according to results of the IMpassion130 clinical trial.

On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.

Another Approval for Keytruda