The U.S. Food and Drug Administration (FDA) has provided an update on various news and developments within the agency. One of the updates highlights the dangers of accidental exposure to nicotine-containing e-liquids found in vape products. The FDA reminds parents to keep these products away from children as they can cause injury and even death. It is also important to be prepared for accidental ingestion or other emergencies related to unintended exposure to e-liquids.
Another update from the FDA announces an open period for applications to support the development of evidence-based, clinical practice guidelines for managing acute low back pain and acute postoperative pain in patients who have undergone diagnostic and procedural laparoscopic abdominal surgeries. These guidelines are part of the FDA’s efforts to prevent unnecessary initial prescription drug exposure and support the Overdose Prevention Framework.
Additionally, the FDA has 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 approval marks the first approval of this drug class for patients without prior treatment for mCRPC with mutations other than BRCA. The approval is based on the results of the TALAPRO-2 study, which showed a 55% reduction in the risk of radiographic progression-free survival (rPFS) compared to placebo with enzalutamide in patients with HRR gene-mutated mCRPC. The study also reported side effects such as anemia, neutropenia, and thrombocytopenia.
Furthermore, the FDA Oncology Center of Excellence Patient-Focused Drug Development team is hosting the Clinical Outcome Assessment in Cancer Clinical Trials 8th annual workshop, either online or in-person on June 27. This workshop aims to facilitate discussions on the use of patient-reported outcome (PRO) measures in cancer clinical trials.
In summary, the FDA has issued updates on the dangers of accidental nicotine exposure in e-liquids, announced an open period for applications to develop clinical practice guidelines for pain management, approved Pfizer’s talazoparib with enzalutamide for the treatment of mCRPC, and is hosting a workshop on PRO measures in cancer clinical trials. These updates showcase the FDA’s commitment to public health and safety.
