FDA approves Komzifti for r/r NPM1-mutated AML https://cancerletter.com/drugs-and-targets/20251114_10a/

Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA Guest editorial by Ellen V. Sigal, PhD (@cancerresearch.bsky.social) https://cancerletter.com/guest-editorial/20251114_2/

Advancing symptom science at City of Hope and across the globe Guest editorial by Jeannine M. Brant, PhD, APRN, AOCN, FAAN (@cityofhope.bsky.social) https://cancerletter.com/sponsored-article/20251114_5/

Smoldering multiple myeloma: Rethinking the waiting game Guest editorial by C. Ola Landgren, MD, PhD https://cancerletter.com/trials-and-tribulations/20251114_4/

Christine Lovly to lead City of Hope’s new national thoracic oncology program (@cityofhope.bsky.social) https://cancerletter.com/in-brief/20251114_8a/

Trump signs CR that funds government through Jan. 30, ending the longest shutdown in U.S. history https://cancerletter.com/cancer-policy/20251114_7a/

FDA to remove black box warnings on hormone therapy for menopause Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence https://cancerletter.com/clinical/20251114_3/

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director https://cancerletter.com/conversation-with-the-cancer-letter/20251114_1/

"We can replace processes that hinder oncology breakthroughs with one that automates, accelerates, and simplifies the genomic testing results needed to make what could be life-saving decisions." - Kathy Davy (Thermo Fisher Scientific). https://cancerletter.com/guest-editorial/20251107_4/

Kunle Odunsi (@uchicagocancer.bsky.social): “One of the areas that I think we need to be thinking about as a community, cancer centers, is how do you reduce the dependence on federal funding to power the enterprise?" https://cancerletter.com/podcastc/20251107_1/

Tidmarsh has resigned from his job as CDER Director in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.” https://cancerletter.com/regulatory-news/20251107_2/

Richard Pazdur, founding director of FDA’s Oncology Center of Excellence and long-time FDA visionary, has accepted the top job at FDA’s Center for Drug Evaluation and Research following George F. Tidmarsh’s dramatic ouster from the position. https://cancerletter.com/podcastc/20251112-tidmarsh/

Michael Deininger, Lesly Dossett, Samuel Kaffenberger join Rogel Cancer Center leadership https://cancerletter.com/in-brief/20251107_7d/

"When it comes to cancer care, geography should never determine a patient’s access to a potentially life-saving clinical trial." Guest editorial by Kathy Davy, MBA. https://cancerletter.com/guest-editorial/20251107_4/

@ameracadpeds.bsky.social: Leucovorin is not recommended for routine use in autistic children https://cancerletter.com/cancer-policy/20251107_6c/

Ruben Mesa: "One of the things that is really rewarding about our field is that it’s very diverse in every way that you can imagine, in terms of background, that really enriches your experience.” https://cancerletter.com/podcastc/20251107_1/

🎙️In the latest episode of The Director, Drs. Odunsi and Mesa emphasize that diversity, international collaboration, and continuous funding support are essential to bring transformative cancer therapies to clinics. Ruben A. Mesa, MD, FACP The Cancer Letter https://ow.ly/Z8NR50XpG05

"After all, the first and foremost job of FDA is to safeguard the health of the public, without the public having to fear undue influence by the very companies the agency is tasked with regulating." - @MikkaelSekeres.bsky.social. https://cancerletter.com/guest-editorial/20251107_3/

The Alliance for Clinical Trials in Oncology appoints new committee leaders https://cancerletter.com/in-brief/20251107_7c/

Some p53 mutations could help fight cancer, Baylor study finds https://cancerletter.com/clinical-roundup/20251107_8b/

"For #LungCancerAwareness Month, let’s reaffirm our commitment to advancing science, improving outcomes, and ultimately, curing lung cancer," writes @cityofhope.bsky.social's Ravi Salgia https://cancerletter.com/sponsored-article/20251107_5/

EMA grants GSK’227 Orphan Drug Designation for pulmonary neuroendocrine carcinoma https://cancerletter.com/drugs-and-targets/20251107_9c

White House makes deal with Eli Lilly, Novo Nordisk to lower weight loss drug prices and begin Medicare coverage https://cancerletter.com/cancer-policy/20251107_6d/

The issues surrounding Tidmarsh’s stunted stint at FDA aren’t limited to the allegations in the Aurinia lawsuit. Another, entirely separate controversy, stems from remarks he made at an industry event four days before his downfall. https://cancerletter.com/regulatory-news/20251107_2/

"These are, indeed, tumultuous times at FDA, and at HHS as a whole, with a tsunami of comings and goings of hundreds of employees over the past few months," writes @MikkaelSekeres.bsky.social. https://cancerletter.com/guest-editorial/20251107_3/

GSK, Empirico enter license agreement for oligonucleotide candidate to treat respiratory diseases https://cancerletter.com/drugs-and-targets/20251107_9b/

Five genes linked to aggressive prostate cancer in men of African descent, @keck.usc.edu study identifies https://cancerletter.com/clinical-roundup/20251107_8a/

“For someone like myself, I don’t think Yale would’ve paid $100,000 to get me an H-1B visa at the time, and I’m sure it’s going to be hard." - Kunle Odunsi (@uchicagocancer.bsky.social) https://cancerletter.com/podcastc/20251107_1/

James Hu named associate director of Sarcoma Program at @CSCancerCenter https://cancerletter.com/in-brief/20251107_7b/

Zongertinib, dostarlimab chosen in second batch of National Priority Vouchers recipients https://cancerletter.com/cancer-policy/20251107_6b/

NCI approved a phase III randomized trial of IO-based systemic treatment +/- liver SBRT in hepatocellular cancer with macrovascular invasion https://cancerletter.com/nci-trials/20251107_10/

FDA approves Darzalex Faspro for high-risk smoldering multiple myeloma https://cancerletter.com/drugs-and-targets/20251107_9a/

City of Hope’s leadership in lung cancer: Precision, innovation, and a vision for cure. Guest editorial by Ravi Salgia, MD, PhD. https://cancerletter.com/sponsored-article/20251107_5/

How next generation sequencing is powering the shift to more accessible—and comprehensive—cancer care. Guest editorial by Thermo Fisher Scientific's Kathy Davy https://cancerletter.com/guest-editorial/20251107_4/

Omar Abdel-Wahab, Andrea Ablasser, Christina Curtis named winners of @mskcme.bsky.social 2025 Paul Marks Prize for Cancer Research https://cancerletter.com/in-brief/20251107_7a/

HHS (again) postpones USPSTF meeting https://cancerletter.com/cancer-policy/20251107_6a/

How George Tidmarsh crossed the FDA-industry Rubicon Guest editorial by @MikkaelSekeres.bsky.social https://cancerletter.com/guest-editorial/20251107_3/

CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct.” Cancer advocates express concern about comments that signal trouble for accelerated approval. https://cancerletter.com/regulatory-news/20251107_2/

The Directors: Ruben Mesa (Atrium Health) and Kunle Odunsi (@uchicagocancer.bsky.social) on how immigration and diversity accelerate discovery “This has always made our environment stronger, not weaker.” https://cancerletter.com/podcastc/20251107_1/

Researchers develop technique to track chemotherapy drug inside cells (@elilillyandcompany.bsky.social, @cancercenteril.bsky.social) https://cancerletter.com/clinical-roundup/20251031_7d/

Robert Winn (@aacicancer.bsky.social): “Having Tony [Letai] come in now as the actual NCI director gives us an opportunity to keep the process potentially within @theNCI, which is what I’m going to advocate for—and that we narrow the site visits." https://cancerletter.com/nci/20251031_1/

According to the amended complaint, SEC has dropped its investigation of Illumina’s acquisition of GRAIL. https://cancerletter.com/clinical/20251031_2/

Eytan Ruppin named deputy director of Translational Research Institute at Cedars-Sinai (@cedarssinaicancer.bsky.social) https://cancerletter.com/in-brief/20251031_6d/

Phippard: "The metabolic reprogramming associated with GLP-1RAs occurs alongside significant changes in gut microbiome composition, immune function, and hormonal signaling pathways—all factors with known implications for cancer biology." https://cancerletter.com/trials-and-tribulations/20251031_4/

Drugs approved for pain also reduce bone cancer growth, Hopkins-led pre-clinical study finds https://cancerletter.com/clinical-roundup/20251031_7c/

“Seamless trial designs can streamline rare cancer drug development by integrating multiple phases into a single, continuous framework," says Bernat Navarro, science policy analyst at Friends of Cancer Research (@cancerresearch.bsky.social) https://cancerletter.com/the-cancer-letter/20251031_3/

Vinai Gondi, Bridget Koontz, Priya Rastogi, Lisa Lenrow named to NRG Oncology committee leadership (@nrgonc.bsky.social) https://cancerletter.com/in-brief/20251031_6c/

Targeted radiation during surgery reduces pancreatic cancer recurrence, Hopkins study finds https://cancerletter.com/clinical-roundup/20251031_7b/

Deborah Phippard (Precision for Medicine): "The intersection of GLP-1RA therapy and oncology warrants ongoing exploration, though emerging evidence suggests both promise and complexity." https://cancerletter.com/trials-and-tribulations/20251031_4/

Senators, nonprofits respond to Trump’s avowed support for IVF (@asrmorg.bsky.social) https://cancerletter.com/cancer-policy/20251031_5c/