FDA Roundup: June 23, 2023

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Jun 23, 2023, 16:02 ET

SILVER SPRING, Md., June 23, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Thursday, the FDA issued an updated Consumer Update to remind parents about the dangers of accidental exposure to nicotine-containing e-liquids (the liquid used in "vape" products). Accidental exposure can cause injury and even death in children. It's important to keep these products away from kids and to be prepared in case of accidental ingestion or other emergencies due to unintended exposure. E-liquids also can harm pets.
On Tuesday and Wednesday, the FDA announced an open period for applications to support the development of evidence-based, clinical practice guidelines for the management of acute low back pain, and acute postoperative pain in patients who have undergone diagnostic and procedural laparoscopic abdominal surgeries. These efforts support the FDA's primary prevention priority under the Overdose Prevention Framework, as they are a key opportunity to eliminate unnecessary initial prescription drug exposure. More information can be found through the following links: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-034.html and https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-035.html
On Tuesday, the FDA approved Pfizer's talazoparib with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This represents the first approval of this class of drugs for patients without prior treatment for mCRPC with mutations in genes other than BRCA and is based on a 55% reduction in the risk of radiographic progression-free survival (rPFS) compared to placebo with enzalutamide in the TALAPRO-2 study that enrolled 399 patients with HRR gene-mutated mCRPC. Efficacy appeared greater in patient with BRCA mutations (80% reduction in rPFS risk) than in those with mutations in other HRR genes (28% reduction in rPFS risk), although this was not tested statistically. Anemia, neutropenia, and thrombocytopenia were reported in the TALAPRO-2 study, with 39% of patients requiring a red blood cell transfusion, including 22% who required multiple transfusions. There is not currently a companion diagnostic to select patients for treatment with talazoparib with enzalutamide; however the company has committed to submit validation studies of both a tissue and a blood-based companion diagnostic as postmarketing commitments. View full prescribing information for talazoparib.
On Tuesday, June 27, the FDA Oncology Center of Excellence Patient-Focused Drug Development team hosts the Clinical Outcome Assessment in Cancer Clinical Trials 8th annual workshop, online or in-person. Each year, this public workshop provides a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. Registration is free.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration