FDA Approvals, News & Updates

On March 11, 2022, the FDA accelerated the approval of the oral PARP inhibitor olaparib (Lynparza; AstraZeneca) for the adjuvant treatment of adults with HER2-negative, high-risk early breast cancer and deleterious or suspected deleterious germline BRCA mutation after neoadjuvant or adjuvant chemotherapy. Read Article ›

On January 25, 2022, the FDA accelerated the approval of tebentafusp-tebn (Kimmtrak; Immunocore), a bispecific gp100 peptide-HLA–­directed CD3 T-cell engager, for the treatment of adults with HLA-A*02:01 unresectable or metastatic uveal (intraocular) melanoma. The FDA granted tebentafusp breakthrough therapy and orphan drug designations for this indication. Read Article ›

On December 15, 2021, the FDA approved a new indication for abatacept (Orencia; Bristol Myers Squibb), a selective T-cell co-stimulation modulator, in combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft-versus-host disease (GVHD) in adults and pediatric patients aged ≥2 years receiving hematopoietic stem-cell transplantation from a matched or 1 allele-mismatched unrelated donor. The FDA granted abatacept a priority review and breakthrough therapy and orphan drug designations. Read Article ›

On December 3, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Key­truda; Merck) for the adjuvant treatment of adult and pediatric patients (age ≥12 years) with stage IIB or IIC melanoma following complete resection. Read Article ›

On November 30, 2021, the FDA approved the combination of subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech) plus carfilzomib (Kyprolis; Amgen) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received 1 to 3 previous lines of therapy. Read Article ›

On November 29, 2021, the FDA accelerated the approval of pafolacianine (Cytalux; On Target Laboratories), a novel fluorescent imaging agent, for adults with ovarian cancer as an adjunct for identifying inoperable malignant lesions. Read Article ›

On October 29, 2021, the FDA granted accelerated approval to asciminib (Scemblix; Novartis) for patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, previously treated with ≥2 tyrosine kinase inhibitors (TKIs). The drug was also granted a full approval for adult patients with Ph+ CML in chronic phase with a T315I mutation. Read Article ›

On September 20, 2021, the FDA accelerated the approval of tisotumab vedotin-tftv (Tivdak; Seagen), a tissue factor-directed antibody and microtubule inhibitor conjugate, for the treatment of women with recurrent or metastatic cervical cancer whose disease progressed during or after chemotherapy. Read Article ›

On October 15, 2021, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small-cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test. Read Article ›

On October 13, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for use in combination with chemotherapy, with or without bevacizumab (Avastin; Genentech), for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Read Article ›