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.
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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August 2, 2023
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.
June 5, 2023
ASCO has issued new clinical guidance for best treating patients with gastrointestinal (GI) cancer amidst a nationwide shortage of carboplatin and cisplatin.
May 31, 2023
On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.
May 24, 2023
The American Society of Clinical Oncology and the Association for Clinical Oncology (collectively ASCO) are closely monitoring the current, acute shortages of cisplatin and carboplatin in the United States. ASCO has developed guidance for clinicians and recommendations to policymakers to help mitigate the current shortages and prevent similar situations in the future. ASCO is also keeping its members up-to-date as supplies of both drugs become available and encourages providers to report shortages and contact their lawmakers about the situation.
May 19, 2023
On May 19, 2023, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
April 27, 2023
The Food and Drug Administration expects additional releases of cisplatin from Accord Healthcare in the upcoming days. Providers and others can check on Accord supplies through their usual channels and can also contact the company directly at 866-941-7875, Option 2. The American Society of Clinical Oncology will keep its members informed as supply becomes available.
April 20, 2023
On April 19, 2023, the Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater.
April 17, 2023
On April 17, 2023, the Food and Drug Administration approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric patients (12 years and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
April 11, 2023
The Association for Clinical Oncology (ASCO) is urging lawmakers to prioritize reducing drug shortages, combatting tobacco use, and improving diversity in research as they review funding requests for fiscal year 2024.
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