FDA Approvals
On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
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Pfizer Oncology is proud to announce the FDA approval of ELREXFIO™ (elranatamab-bcmm).
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Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced on August 2, 2023 that the FDA has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
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Coding and Reimbursement Updates
View the August E-Reimbursement Newsletter
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For the first time, the law provides Medicare the ability to directly negotiate the prices of certain high expenditure, single source drugs without generic or biosimilar competition. These 10 drugs are covered under Medicare Part D and selected for negotiation for initial price applicability year 2026, based on total gross covered prescription drug costs under Medicare Part D and other criteria as required by the IRA (Inflation Reduction Act).
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State and National Legislative & Regulatory Issues
The American Society of Clinical Oncology (ASCO) recently released a position statement on white bagging. The statement was developed in close consultation with leading ASCO volunteers and affirms ASCO’s opposition to the mandated use of white bagging.
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