FDA Approvals, News & Updates

On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication an orphan drug designation. Read Article ›

On May 25, 2022, the FDA accelerated the approval of ivosidenib tablets (Tibsovo; Servier Pharmaceuticals) in combination with azacitidine tablets (Onureg; Celgene) for newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years, or patients with comorbidities that preclude the use of intensive induction chemotherapy. Read Article ›

On May 20, 2022, the FDA accelerated the approval of a new indication for azacitidine injection (Vidaza; Celgene) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). Read Article ›

On May 4, 2022, the FDA granted a regular full approval for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for adults with unresectable or metastatic HER2-positive breast cancer who had previously received an anti-HER2 regimen in the metastatic or the neoadjuvant or adjuvant setting whose disease recurred during or within 6 months of completing therapy, based on the confirmatory DESTINY-Breast03 clinical trial. Read Article ›

On April 1, 2022, the FDA accelerated the approval of a new indication for the CAR T-cell therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. Read Article ›

On April 14, 2022, the FDA released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials.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