Richard L. Schilsky, MD, FACP, FSCT, FASCO, Senior Vice President and Chief Medical Officer of ASCO will moderate a panel at an upcoming public meeting of the Reagan-Udall Foundation for the Food and Drug Administration (FDA) on November 19, 2018, at the FDA main campus at White Oak.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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On October 17, the Journal of the National Cancer Institute published a manuscript summarizing the action items coming out of the joint ASCO/U.S. Food and Drug Administration Geriatric Oncology Workshop, held Nov. 6, 2017.
On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA®, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
On October 4, 2018, the Food and Drug Administration approved emicizumab-kxwh injection (HEMLIBRA®, Genentech, Inc.) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors.
On September 28, 2018, the Food and Drug Administration approved cemiplimab-rwlc (LIBTAYO®, Regeneron Pharmaceuticals Inc.) for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
On September 27, 2018, the Food and Drug Administration approved dacomitinib tablets (VIZIMPRO, Pfizer Pharmaceutical Company) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
On September 24, 2018, the Food and Drug Administration granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.
Last week, the Food and Drug Administration (FDA) announced a series of critical enforcement actions related to the sale and marketing of e-cigarettes to children and young adults. With the use of e-cigarettes among youth growing at an alarming rate in recent years, the agency has taken record actions to address this challenge and protect youth from the dangers of tobacco products through its Youth Tobacco Prevention Plan.
On Sept. 13, 2018, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (LUMOXITITM, AstraZeneca Pharmaceuticals LP), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
CancerLinQ LLC, a wholly-owned nonprofit subsidiary of the ASCO, has brought on technology collaborators Concerto HealthAI and Tempus to accelerate its joint research effort with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) aimed at understanding the real-world use, tolerability, and effectiveness of immune checkpoint inhibitors. Concerto HealthAI and Tempus have begun to assist in the analysis of a de-identified data set that CancerLinQ has provided to the FDA, representing more than 10,000 patients who have been treated with immune checkpoint inhibitors for both approved and unapproved indications.
On August 20, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.
On August 16, 2018, the Food and Drug Administration granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company Inc.) for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.
On August 16, 2018, the Food and Drug Administration approved lenvatinib capsules (Lenvima®, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
On August 16, 2018, the Food and Drug Administration updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible.
ASCO and Friends of Cancer Research have submitted to the Food and Drug Administration recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.