The Lynx Group

FDA Approvals, News & Updates

On March 18, 2022, the FDA approved the combination of 2 distinct immune checkpoint inhibitors, the new LAG-3 antibody relatlimab-rmbw (Opdualag; Bristol Myers Squibb) plus the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), for patients aged ≥12 years with unresectable or metasta­tic melanoma.
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On February 28, 2022, the FDA accelerated the approval of pacritinib (Vonjo; CTI BioPharma), a kinase inhibitor, for the treatment of adult patients with intermediate- or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
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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 adult patients with HLA-A*02:01 unresectable or metastatic uveal (intraocular) melanoma.
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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 previous systemic therapy in any setting and who are not candidates for curative surgery or radiation.
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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. Patients must be selected for olaparib therapy for this indication based on an FDA-approved test.
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On March 4, 2022, the FDA accelerated the approval of the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb) in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of adults with resectable non–small-cell lung cancer (NSCLC). This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC.
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On October 29, 2021, the FDA granted accelerated approval to asciminib (Scemblix; Novartis) for the treatment of patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, previously treated with ≥2 tyrosine kinase inhibitors.
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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.
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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.
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On October 12, 2021, the FDA approved a new indication for the cyclin-dependent kinase 4/6 inhibitor abemaciclib (Verzenio; Eli Lilly), in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy, for the treatment of adult patients with hormone receptor-positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence, and a Ki-67 score ≥20%, as determined by an FDA-approved test.
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