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New Permanent J-Code for Melphalan Flufenamide
Oncopeptides announces J-code J9247 for Pepaxto® (melphalan flufenamide) injection, 1mg. This J-code will be effective on October 1, 2021.
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FDA Approves Nivolumab for High-Risk Urothelial Carcinoma
On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab—240 mg every two weeks or 480 mg every four weeks—for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or programmed death-ligand 1 (PD-L1) status.
Read the FDA announcement.
Posted 8/20/2021
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FDA Approves Belzutifan for von Hippel-Lindau Disease-Associted Tumors
On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan, a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Read the FDA announcement.
Read the Merck announcement.
Posted 8/16/2021
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FDA Approves Levnatinib + Pembrolizumab for Advanced RCC
On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Read the FDA announcement.
Read the Eisai announcement.
Posted 8/16/2021
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FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC
On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.
Read Merck's announcement.
Posted 7/27/2021
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FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer
On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Read the FDA announcement.
Read the Merck announcement.
Read the Eisai Inc. announcement.
Posted 7/22/2021
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FDA Grants Regular Approval + New Indication to Enfortumab Vedotin-ejfv
On July 9, 2021, Astellas Pharma Inc. and Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to enfortumab vedotin-ejfv. The FDA also approved a new indication for enfortumab vedotin-ejfv for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and who have previously received one or more prior lines of therapy.
Read the FDA announcement.
Read the SeaGen announcement.
Posted 7/9/2021
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FDA Approves Expanded Indication for Pembrolizumab for cSCC
On July 6, 2021, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab as a monotherapy treatment for patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Read Merck's announcement.
Posted 7/6/2021
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Updated Data for Durvalumab
Durvalumab (Imfinzi®, AstraZeneca) offers the best chance for long-term survival in a curative intent setting. This update comes after the post-hoc analysis of 5-year overall and progression-free survival data had been released for the PACIFIC trial, a large, Phase III, randomized, double-blind, placebo-controlled, multicenter study of 713 patients with unresectable Stage III NSCLC. The primary overall survival analysis was reported at 2 years (25.2 months median follow-up). For more information, click here.
Posted 6/10/2021
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FDA Approves Sotorasib for KRAS G12C-Mutated NSCLC
The U.S. Food and Drug Administration (FDA) has approved sotorasib (LUMAKRASTM, Amgen) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Sotorasib has received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Read press release.
Posted on 6/1/2021