FDA grants fast track designation to therapies for lung, brain and prostate cancers
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The FDA announced several regulatory actions.
Here is an overview of decisions that may be relevant to your practice.
1. The FDA granted fast track designation to BI 764532 (Boehringer Ingelheim/Oxford BioTherapeutics) — a DLL3/CD3 IgG-like T-cell engager — for treatment of two populations. One applies to patients with extensive-stage small cell lung cancer whose disease progressed after at least two prior lines of therapy, including platinum-based chemotherapy. The other applies to patients with advanced or metastatic extrapulmonary neuroendocrine carcinomas whose disease progressed after at least one prior line of treatment, including platinum-based chemotherapy.
2. The agency granted fast track designation to SurVaxM (MimiVax). SurVaxM — developed at Roswell Park Comprehensive Cancer Center — is an immunotherapy that targets survivin, a protein present in many cancer types that enables cancer cells to survive. Trials are underway across the country to evaluate the therapy for treatment of adults and children with certain brain tumors.
3. The FDA granted priority review to osimertinib (Tagrisso, AstraZeneca) — an EGFR tyrosine kinase inhibitor — in combination with chemotherapy for treatment of adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
4. The agency granted fast track designation to ONCT-534 (Oncternal Therapeutics) — a dual-acting androgen receptor inhibitor — for treatment of relapsed or refractory metastatic castration-resistant prostate cancer resistant to approved androgen receptor pathway inhibitors.
References:
- Oxford BioTherapeutics announces partner Boehringer Ingelheim received U.S. FDA fast track designation for BI 764532 for the treatment of extensive stage small cell lung cancer and extrapulmonary neuroendocrine cancers (press release). Available at: http://www.oxfordbiotherapeutics.com/uploads/9/5/4/2/9542591/03_10_23_bi_764532_fast_track_pr.pdf. Published Oct. 3, 2023. Accessed Oct. 3, 2023.
- Roswell Park cancer innovation SurVaxM granted FDA fast track designation (press release). Available at: https://www.roswellpark.org/newsroom/202310-roswell-park-cancer-innovation-survaxm-granted-fda-fast-track-designation. Published Oct. 13, 2023. Accessed Oct. 14, 2023.
- Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR-mutated advanced lung cancer (press release). Available at: https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-plus-chemotherapy-granted-priority-review-us-patients-egfr-mutated-advanced-lung-cancer.html. Published Oct. 16, 2023. Accessed Oct. 16, 2023.
- Oncternal Therapeutics announces FDA granted fast track designation for ONCT-534 for the treatment of metastatic castration-resistant prostate cancer (press release). Available at: https://investor.oncternal.com/news-releases/news-release-details/oncternal-therapeutics-announces-fda-granted-fast-track. Published Oct. 26, 2023. Accessed Oct. 26, 2023.
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