FDA Approvals, News & Updates

On July 16, 2021, the FDA approved belumosudil (Rezurock; Kadmon Holdings), a kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after failure of ≥2 previous lines of systemic therapy. The FDA granted belumosudil breakthrough therapy designation and priority review for this indication. Read Article ›

On June 30, 2021, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to Escherichia coli–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication. Read Article ›

On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. Read Article ›

On July 9, 2021, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), in combination with pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone, for the treatment of adults with multiple myeloma who have received ≥1 previous lines of therapy, including lenalidomide (Revlimid) or a proteasome inhibitor. Daratumumab and hyaluronidase, as well as pomalidomide, are each already approved for the treatment of patients with multiple myeloma, alone or in combination with other drugs. Read Article ›

On June 16, 2021, the FDA approved a new indication for avapritinib (Ayvakit; Blueprint Medicines) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast-cell leukemia. The FDA granted this indication a priority review and breakthrough therapy and orphan drug designations. Read Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›