FDA Approvals, News & Updates

On July 21, 2021, the FDA granted full approval for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), in combination with the kinase inhibitor lenvatinib (Lenvima; Eisai), for the treatment of advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair-deficient), in patients whose disease progressed after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation. Read More ›

Although standard chemotherapy is often effective in the first-line treatment of locally invasive urothelial carcinoma, until recently, there have been few second- or third-line treatment options for patients with advanced or metastatic disease. During the 2021 Hematology/Oncology Pharmacy Association Annual Conference, Renee K. McAlister, PharmD, BCOP, Oncology Clinical Pharmacy Specialist, Melanoma/Genitourinary Oncology Clinics, Vanderbilt University Medical Center, Nashville, TN, discussed promising results from clinical trials evaluating the use of erdafitinib (Balversa) and enfortumab vedotin (Padcev), 2 FDA-approved drugs that are changing the therapeutic landscape for metastatic urothelial cancer. Read More ›

On May 28, 2021, the FDA granted accelerated approval to infigratinib (Truseltiq; QED Therapeutics, Inc), an oral FGFR1-3 selective inhibitor, for the treatment of adults with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or other rearrangement. The FDA previously granted infigratinib orphan drug and fast-track designations. Read More ›

On May 28, 2021, the FDA accelerated the approval of sotorasib (Lumakras; Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after ≥1 systemic therapies. The FDA granted sotorasib orphan drug and breakthrough therapy designations. Read More ›

On May 21, 2021, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the EGFR and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication. Read More ›

On May 5, 2021, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read More ›

On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA granted sacituzumab govitecan priority review and a fast-track designation for this indication. Read More ›

On April 16, 2021, the FDA approved nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, in combination with certain types of chemotherapy, for the initial treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The FDA granted nivolumab priority review and an orphan drug designation for this indication. Read More ›

On March 27, 2021, the FDA approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb/Bluebird Bio), a B-cell maturation antigen–directed, genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or recurred, after ≥4 lines of therapy. Idecabtagene vicleucel is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. The FDA granted idecabtagene vicleucel orphan drug and breakthrough therapy designations. Read More ›

On April 22, 2021, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a previous platinum-containing regimen. The FDA granted dostarlimab priority review and a breakthrough therapy designation for this indication. Read More ›