FDA Approvals, News & Updates

On April 14, 2022, the FDA released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. Read Article ›

On March 23, 2022, the FDA accelerated the approval of lutetium Lu 177 vipivotide tetraxetan, formerly known as 177Lu PSMA-617 (Pluvicto; Novartis/Advanced Accelerator Applications), for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after receiving an androgen receptor (AR) inhibitor and taxane-based chemotherapy. Read Article ›

On March 18, 2022, the FDA approved the combination of 2 types of immune checkpoint inhibitors, the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb) plus the novel LAG-3 inhibitor relatlimab-rmbw (Opdualag; Bristol Myers Squibb), for patients aged ≥12 years with unresectable or metastatic melanoma. Read Article ›

On February 28, 2022, the FDA approved ciltacabtagene autoleucel (Carvykti; Janssen Biotech) for the treatment of adults with relapsed or refractory multiple myeloma after ≥4 lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. Read Article ›

On March 21, 2022, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) as monotherapy for advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR), as determined by an FDA-approved test, in patients whose disease progressed after systemic therapy in any setting and who are not candidates for curative surgery or radiation therapy. Read Article ›

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 ›

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