Cisplatin has been in shortage since February 2023 (per FDA data), and the shortage has grown particularly acute in the last week or two. Accord/Intas released a cisplatin lot this week and subsequent releases are expected.
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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April 3, 2023
ASCO outlines the National Cancer Institute's National Cancer Plan and what it means for progress in cancer care, treatment, and access.
April 3, 2023
The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:
On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
March 28, 2023
Strengthen the Strategic National Stockpile to Protect Individuals With Cancer in Future Emergencies
The Association for Clinical Oncology (ASCO) submitted a response to the House Energy and Commerce Committee’s Request for Information (RFI) on the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). The legislation includes numerous programs, like the Strategic National Stockpile (SNS), that aid the U.S. in preparing for and responding to public health emergencies.
March 28, 2023
The Association for Clinical Oncology (ASCO) submitted a statement to the U.S. Senate Committee on Homeland Security and Government Affairs for a hearing titled, “Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms.” ASCO’s statement highlighted the current drug shortages facing the oncology community and offered specific recommendations to help mitigate them.
March 22, 2023
On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
March 17, 2023
On March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.
March 6, 2023
On March 3, 2023, the Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
February 9, 2023
On February 9, 2023, the Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
February 8, 2023
“ASCO applauds President Biden’s focus on ‘ending cancer as we know it’ during the State of the Union address. We continue to urge the president to keep cancer care and research as top national priorities and are pleased with his plans to advance efforts to strengthen the Cancer Moonshot, improve cancer clinical trials, and foster breakthroughs through the Advanced Research Projects Agency for Health (ARPA-H).”
February 3, 2023
On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
January 27, 2023
On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
January 27, 2023
On January 27, 2023, the Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
January 26, 2023
On January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).
January 20, 2023
On January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
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