The House Energy and Commerce Subcommittee on Health will hold a hearing today on several bills aimed at addressing the ongoing U.S. drug shortage crisis. Many of the bills contain provisions the Association for Clinical Oncology (ASCO) supports as effective means to mitigate and prevent drug shortages and promote a more resilient supply chain in the future.
ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.
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September 14, 2023
September 12, 2023
The Association for Clinical Oncology (ASCO) is continuing to work advocating for solutions to the cancer drug shortage crisis. ASCO responded to a Request for Information from House Energy & Commerce Committee Chair Cathy McMorris Rodgers and Senate Finance Committee Ranking Member Mike Crapo, and subsequently provided feedback on a discussion draft of potential legislation addressing drug shortages. The Association’s comments noted the meaningful progress toward addressing the root causes of drug shortages and offered specific feedback on proposals.
August 15, 2023
On August 14, 2023, the Food and Drug Administration approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
August 14, 2023
On August 14, 2023, the Food and Drug Administration granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
August 14, 2023
On August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
August 10, 2023
On August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
August 9, 2023
September 6-7, the Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) are holding a free virtual workshop ondose optimization, a critical issue in oncology and in improving the quality of life for patients with cancer. This timely FDA-ASCO workshop will bring together thought leaders and others from academia, industry, regulatory agencies, and patient groups to discuss challenges and opportunities to improve dose selection for patients, specifically for combination therapies.
August 9, 2023
On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
August 2, 2023
On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for 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. FDA had previously approved single-agent LONSURF for this indication in September 2015.
July 31, 2023
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).
July 20, 2023
On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.
July 18, 2023
The Association for Clinical Oncology (ASCO) responded to a bicameral Request for Information (RFI) on the underlying factors driving drug shortages. The Association’s comments highlighted the impact of the shortages on patient care and pointed to economic failures and supply chain vulnerabilities that have led to shortages of critical oncology drugs for more than a decade.
June 20, 2023
On June 20, 2023, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
June 16, 2023
On June 15, 2023, the Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
June 13, 2023
The Association for Clinical Oncology (ASCO) continues to urge Congress to help prevent and mitigate cancer drug shortages by reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA) with provisions to improve the function and composition of the Strategic National Stockpile (SNS) to strengthen the drug and medical supply chain. On June 13, 2023, ASCO’s Chief Medical Officer and Executive Vice President Julie R. Gralow, MD, FACP, FASCO, testified in a House Energy and Commerce Health Subcommittee hearing on solutions for preparedness and response to public health security threats and hazards, including PAHPA reauthorization and its programs aimed at strengthening the SNS.
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