The American Association for Cancer Research released its 16th annual Cancer Progress Report highlighting major scientific advances while warning that federal funding cuts threaten future research. Pennsylvania senators are pressing the Trump administration over millions in cuts to health research funding at institutions like the University of Pittsburgh.
The US Food and Drug Administration has granted expanded accelerated approval for sevabertinib as a frontline treatment option for patients with HER2-mutant advanced non-small cell lung cancer, with nursing management focusing on diarrhea monitoring.
Bristol Myers Squibb reported its experimental GPRC5D-directed CAR-T cell therapy achieved a high overall response rate in a mid-stage trial for patients with hard-to-treat multiple myeloma who had progressed after prior CAR-T treatment.
The U.S. Food and Drug Administration approved Mimrylo (rusfertide), developed by Takeda Pharmaceutical and Protagonist Therapeutics, as the first drug of its kind to treat polycythemia vera, a rare blood disorder that causes overproduction of red blood cells.
Revolution Medicines' breakthrough pill targeting KRAS mutations in advanced pancreatic cancer received FDA approval, priced at over $475,000 per year. The drug nearly doubles survival in patients with this hard-to-treat cancer.
Pathos AI announced two significant licensing agreements for breast cancer treatments: a $2.2 billion deal with China's Alphamab Oncology for bispecific ADC JSKN016 targeting triple-negative breast cancer, and a co-exclusive agreement with AstraZeneca for ERα degrader AZD4241 for ER-positive breast cancer. The company is reportedly planning to raise a Series E round at a $3 billion valuation.
The FDA has approved Novartis' radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in combination with hormone therapy for patients with PSMA-positive metastatic prostate cancer who are still hormone-sensitive, nearly doubling the eligible patient population from its previous indication for hormone-resistant cases.
Hansoh Pharmaceutical announced positive results from the ARTEMIS-011 Phase III trial in China, with its experimental drug Ris-Rez meeting the primary endpoint of progression-free survival in relapsed bone cancer patients. This marks the second Phase III success for the drug, strengthening GSK's oncology portfolio through its licensing partnership with the Chinese biotech.
The FDA has approved SimpleScreen CRC, a blood-based screening test for colorectal cancer, marking the second such test to receive approval. The less invasive option aims to improve screening uptake as colorectal cancer cases rise approximately 3 percent annually in adults under 50.
AstraZeneca announced Monday that its rare disease drug Ultomiris failed a late-stage trial for blood vessel complications following stem cell transplants, while a separate trial of its Claudin 18.2-targeting antibody-drug conjugate in stomach cancer succeeded. The Ultomiris setback adds to concerns about the drugmaker's pipeline following a series of setbacks this year.
Phase III CLARITY-Gastric01 trial results showed sonesitatug vedotin (Sone-Ve) achieved statistically significant overall survival improvement in CLDN18.2-positive advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma patients in second-line and later settings, meeting its dual primary and key secondary endpoints.
The U.S. Food and Drug Administration has approved Revtorpyk (gedatolisib), Celcuity's first drug to reach market, for treating hormone receptor positive, HER2 negative advanced breast cancer. The approval sent the company's shares up 7% in extended trading.
The FDA has approved Sanofi's Sarclisa (isatuximab) for subcutaneous delivery via a wearable on-body injector, marking the first cancer drug to receive approval for this delivery method. The device offers multiple myeloma patients a less burdensome alternative to intravenous infusions.
China's National Medical Products Administration has approved satricabtagene autoleucel (Satri-cel, CT041, Kaileimei®), marking the first CAR-T cell therapy approved globally for treating solid tumors, specifically for CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction adenocarcinoma.
The FDA has approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda) as adjuvant treatment for patients with clear cell renal cell carcinoma at high risk of recurrence following nephrectomy, based on data from the phase 3 LITESPARK-022 trial.
UK pharmaceutical giant GSK has entered an agreement to acquire U.S.-based cancer drugmaker Nuvalent for $10.6 billion, adding targeted cancer therapies to its portfolio in one of the year's largest biopharma acquisitions.
ADC Therapeutics shares plunged 53% in premarket trading after a late-stage study of its blood cancer drug showed more deaths among treated patients, despite meeting its main goal. The safety signal represents a significant setback for the company's development program.
J&J's Erleada used with hormone-blocking therapy six months before and after prostate surgery improved cancer elimination rates and reduced the risk of cancer spread and death in a late-stage trial for prostate cancer patients.
The first randomized phase 3 trial comparing radiation schedules found that delivering stereotactic radiation over three to five sessions after surgery significantly improved local control and reduced cancer recurrence at the surgical site for patients with large, resected brain metastases compared with single-fraction treatment.
Scientists have developed a DNA test that can distinguish between breast cancer patients who are likely to benefit from chemotherapy and those who can safely avoid it, potentially sparing millions from unnecessary treatment.
Chinese innovative drug NHWD-870 has received Breakthrough Therapy Designation for NUT carcinoma, a rare and aggressive cancer that has historically had very poor outcomes. The designation represents a significant milestone for patients with this previously untreatable condition.
Setidegrasib, an investigational targeted therapy drug, demonstrated ability to slow cancer growth and shrink tumors in a first-in-human clinical trial published in the New England Journal of Medicine, targeting a previously difficult-to-treat cancer mutation.
Clinical trial results demonstrate that immunotherapy as first-line treatment provides clinical benefit for patients with advanced colorectal cancer, offering an alternative to chemotherapy for a disease increasingly affecting younger patients.
Revolution Medicines presented new positive clinical trial data at AACR for its KRAS-targeting drug in pancreatic cancer patients, building on previously reported breakthrough survival results and expanding evidence for a novel class of treatments beyond current KRAS inhibitors.
Allogene Therapeutics reported new data showing its allogeneic (off-the-shelf) CAR-T treatment successfully eliminated residual cancer cells in B-cell lymphoma patients, potentially offering an easier-to-administer alternative that could delay or prevent cancer recurrence.
