The FDA's recent "pooled analysis" publications are awesome! Sure, these evaluations are still exploring the data, but they're incredibly insightful and pave the way for future research. Huge thanks and congrats to everyone at the FDA who made these studies happen 👏👏👏

congratulations and hats off to Jaleh Fallah and the FDA Oncology team for putting together these data in a single analysis. This was much needed! PCF Science

Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Met Castration-Resistant Prostate Cancer: U.S. FDA Pooled Analysis [Mar 14, 2024] Jaleh Fallah et al Journal of Clinical Oncology ascopubs.org/doi/10.1200/JC… #pcsm #PrecisionMedicine

Listen to the Uromigos podcast "FDA and Oncology Clinical Trials" 💯 podcasts.apple.com/gb/podcast/epi… FDA Oncology Uromigos Paul Kluetz

Jaleh Fallah FDA Oncology Uromigos Paul Kluetz Dan does a great job explaining very complex regulatory issues. Brian and Tom asked very insightful questions. Very timely answers on accelerated approval and neoadjuvant/adjuvant trials.

✍🏽 DYK? FDA Oncology medical reviewers wrote more than 500 articles for peer-reviewed journals from 2018-2023—articles about regulatory issues, drug approval summaries, and scientific analyses of clinical trial data. 💻 fda.gov/about-fda/onco… #OCEPublications #OCECareers

FDA published PARPi results by biomarker. Largest to date — confirming prior data that ATM and CHEK2 have poor response. High number for BRCA, CDK12, PALB2 adds confidence for good ORR + PFS ascopubs.org/doi/abs/10.120…

Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis | Journal of Clinical Oncology ascopubs.org/doi/10.1200/JC…

Applications for the 2024-25 FDA-AACR Oncology Educational Fellowship open today, June 1, and are due Aug 14. Early-career cancer investigators or clinicians with an advanced degree (DO, MD, PhD, etc.) within the past 10 years encouraged to apply. aacr.org/professionals/…

Applications for the 2024-25 FDA-AACR Oncology Educational Fellowship are due Aug 14. Early-career cancer investigators or clinicians with an advanced degree (DO, MD, PhD, etc.) within the past 10 years encouraged to apply. aacr.org/professionals/… #MedEd #ODACOdyssey

academic.oup.com/jnci/advance-a…

Just published JCO Precision Oncology False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring ATM and CHEK2 Mutations. Jaleh Fallah / Daniel Suzman ascopubs.org/doi/pdf/10.120…

Pediatric cancer advocates—We want to hear from you! Registration is open for the Oct. 15 FDA Oncology Center of Excellence Pediatric Advocacy Forum. Virtual or In-person attendance options are available ⤵️ fda.gov/news-events/fd…

FDA's Oncologic Drugs Advisory Committee is scheduled on 9/26, 8am-6pm, to discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. fda.gov/advisory-commi… #FDAODAC

Commentary: Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies | Journal of Clinical Oncology via Journal of Clinical Oncology. 1st author Jaleh Fallah last author Paul Kluetz. ascopubs.org/doi/full/10.12…

Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies | Journal of Clinical Oncology ascopubs.org/doi/pdf/10.120…

Autopsy of a Drug Withdrawal — The Case of Melphalan Flufenamide | New England Journal of Medicine nejm.org/doi/full/10.10…

Investigational Use Requirements for In Vitro Diagnostic Products (IVDs), including Laboratory Developed Tests (LDTs) Under 21 CFR 812 - 02/25/2025 fda.gov/medical-device…

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials fda.gov/news-events/pr…

Just published: FDA Cancer Therapy Approvals in 2024: New Options for Patients Across Cancer Types and Therapeutic Classes, in NatureRevClinOncol. nature.com/articles/s4157…