The FDA granted accelerated approval to Replimune's TUDRIQEVTM (vusolimogene oderparepvec-wtpg) for melanoma treatment, reversing two earlier rejections following support from an advisory panel. The approval marks a significant turnaround for the biotech company after a tumultuous regulatory process.
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee determined that efficacy data from Replimune's Ignyte study for RP1 is evaluable and clinically meaningful, voting 10 to 3 in favor.
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.
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.
Roche announced positive results from a head-to-head Phase 3 trial showing its KRAS G12C inhibitor divarasib demonstrated superior efficacy compared to competing treatments from Amgen and Bristol Myers Squibb in patients with KRAS-driven lung cancer.
The FDA has approved Vertex Pharmaceuticals' Casgevy (exagamglogene autotemcel) for patients aged two years and older with sickle cell disease and transfusion-dependent beta thalassemia, expanding from the previous minimum age of 12 years. The approval was granted under the agency's Commissioner's National Priority Voucher program.
The U.S. FDA has approved Orca Bio's TREGZI, the first precision-engineered cell therapy for allogeneic transplants in adults with hematological malignancies, designed to reduce stem cell transplant complications.
The EPCORE DLBCL-4 Phase 3 trial showed that epcoritamab (Epkinly) combined with lenalidomide significantly improved progression-free survival compared to R-GemOx chemotherapy in adults with relapsed or refractory diffuse large B-cell lymphoma who received at least one prior line of therapy. The results bring the bispecific antibody closer to a potential label expansion.
The FDA approved sacituzumab govitecan-hziy (Trodelvy) on June 24, 2026, for two indications in adults with triple-negative breast cancer: as monotherapy and in combination with pembrolizumab (Keytruda) for first-line treatment of advanced disease, offering new options beyond standard chemotherapy.
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.
New clinical trial results presented at the American Society of Clinical Oncology show that Moderna's experimental personalized mRNA vaccine, combined with immunotherapy, significantly reduced the risk of deadly melanoma returning after five years. The vaccine is custom-made for each patient based on their specific tumor.
Ivonescimab, an experimental drug combining two immunotherapy mechanisms, reduced the risk of death by 34% compared to standard immunotherapy in patients with advanced squamous non-small cell lung cancer in a closely watched Chinese trial. The drug helped patients live 15% longer than BeOne Medicines' Tevimbra.
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.
Clinical trial results show that daraxonrasib, an experimental daily pill, nearly doubled overall survival rates for patients with advanced pancreatic cancer compared to traditional chemotherapy. Medical experts are calling the results a 'game changer' for treating one of the deadliest forms of cancer.
Novartis reported early data showing its experimental actinium-based radiopharma drug demonstrated anti-tumor activity against prostate cancer, including in patients previously treated with its older therapies.
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.
