Clinical Trial News

Nuvation Bio's NDA for taletrectinib, a next-gen ROS1 TKI for advanced ROS1+ NSCLC, has been accepted by the FDA with a PDUFA goal date of June 23, 2025. Taletrectinib, supported by Phase 2 TRUST studies, shows potential as a best-in-class treatment with durable responses and prolonged PFS.

The FDA added a boxed warning for rare but serious liver injury to fezolinetant (Veozah) labeling, emphasizing hepatotoxicity and increased LFT testing. A postmarketing report detailed a patient's severe hepatic injury, resolved after treatment cessation. Fezolinetant, approved in May 2023 as the first non-hormonal VMS treatment, restores neurokinin B balance disrupted by menopause. The updated prescribing info includes monthly LFT testing for 2 months post-initiation, then at 3, 6, and 9 months, with immediate discontinuation upon liver injury symptoms.

US FDA approved crinecerfont (Crenessity) for congenital adrenal hyperplasia (CAH) in adults and children aged 4+; first new therapy for CAH in 70 years. Indicated as adjunctive treatment to glucocorticoid replacement therapy, it reduces excess adrenal androgens. Based on phase 3 CAHtalyst trial data.

Sumitomo Pharma America announces FDA approval of GEMTESA® (vibegron), the first β3 agonist for men with OAB symptoms on pharmacological therapy for BPH, available for prescription in the U.S.

Axena Health announces a feasibility study in Nigeria using the Leva® Pelvic Health System for female incontinence, supported by ArcHealth Foundation. The study aims to assess a clinic-based treatment program combining Leva technology with a home-based digital health education and pelvic floor muscle training (PFMT) program. The trial will enroll 60 women at two Nigerian hospitals to evaluate the acceptance and success of the treatment.

A double-blind, placebo-controlled clinical trial evaluated ProBC Plus (Bacillus coagulans LMG S-31876) for stress relief, immune status, lipid parameters, and vital signs. Results showed significant improvements, indicating its safety and effectiveness for overall well-being.

The CheckMate 73L study found that adding nivolumab to concurrent chemoradiation followed by nivolumab plus ipilimumab did not significantly improve progression-free survival over chemoradiation followed by durvalumab in patients with stage III NSCLC. Median PFS was 16.7 months vs 15.6 months, missing the primary endpoint. Median overall survival was 34.6 months vs 40.2 months. Objective response rates were 68% vs 64%. No new safety signals were observed, but pneumonitis increased with concurrent immunotherapy and chemoradiation.

Puma Biotechnology announced NCCN updated cervical cancer guidelines to include neratinib for HER2-mutated tumors. This addition is based on the Phase II SUMMIT trial results, offering neratinib as a second-line therapy option for patients with HER2-mutated recurrent or metastatic cervical cancer.

The U.S. FDA accepted Nuvation Bio's NDA for taletrectinib, a ROS1 TKI for advanced ROS1+ NSCLC, for Priority Review, with a PDUFA goal date of June 23, 2025. The NDA is based on Phase 2 TRUST-I and TRUST-II studies showing durable responses and prolonged PFS in ROS1+ NSCLC patients. Taletrectinib could be a best-in-class treatment option for this patient population.

Puma Biotechnology announced NCCN updated cervical cancer guidelines to include neratinib monotherapy for HER2-mutated tumors, based on Phase II SUMMIT trial results.