Pembrolizumab Receives Full Approval for Select Patients With MSI-H or dMMR Solid Tumors
March 29th 2023The FDA has granted full approval to pembrolizumab for the treatment of some patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment.
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FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast Cancer
March 7th 2023The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.
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Cemiplimab Plus Chemotherapy Approaches EU Approval for PD-L1–Positive NSCLC
March 2nd 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab-rwlc in combination with platinum-based chemotherapy as frontline treatment for adult patients with advanced non–small-cell lung cancer with PD-L1 expression of 1% or higher.
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FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
January 28th 2023The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a previous Bruton tyrosine kinase (BTK) inhibitor.
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