The FDA has approved Keytruda (pembrolizumab; Merck), a programmed death receptor-1 -blocking antibody, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Tazverik, a methyltransferase inhibitor, is already indicated for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
The FDA has approved Zepzelca™ (lurbinectedin; Jazz Pharmaceuticals) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
The FDA has approved Cyramza (ramucirumab; Lilly) in combination with erlotinib, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The FDA has approved Alunbrig® (brigatinib; Takeda) as a first-line treatment of adults with anaplastic lymphoma kinase(ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
The approval was based on data from the phase 3 IMpower110 study that compared the efficacy and safety of atezolizumab monotherapy to platinum-based chemotherapy in PD-L1-selected, chemotherapy-naive patients with stage IV NSCLC without ALK or EGFR mutations.
The FDA has approved Lynparza® (olaparib; AstraZeneca and Merck) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
The FDA has granted accelerated approval to Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
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.
