Key facts
- The European Commission approved Amgen's Imdyetra for extensive-stage small cell lung cancer.
- Phase 3 trial results showed Imdyetra reduced the risk of death by 40% compared to chemotherapy.
European regulators have approved Amgen's Imdyetra for extensive-stage small cell lung cancer, based on trial data showing a 40% reduction in death risk. In other oncology news, AstraZeneca reported positive trial results for its Imfinzi and Imjudo combination therapy in liver cancer. IDEAYA Biosciences and Roche are collaborating on a pancreatic cancer drug trial, with IDEAYA receiving upfront and potential milestone payments. OrthAlign secured FDA clearance for its cost-effective Lantern ASC orthopedic navigation system, while Photocure ASA acquired Vesica Health Inc. to bolster its bladder cancer diagnostics. Mammotome received CE mark approval for its breast biopsy markers in Europe, and Exigent Research Network appointed Nina Chavez as Senior Vice President of Growth.
The European Commission has granted approval for Amgen's Imdyetra, a new treatment option for patients with extensive-stage small cell lung cancer. This decision follows Phase 3 trial results that demonstrated a significant 40% reduction in the risk of death when compared to standard chemotherapy, offering a new therapeutic avenue for this patient population.
In other oncology developments, AstraZeneca announced positive outcomes from a clinical trial involving its Imfinzi and Imjudo combination therapy for unresectable hepatocellular carcinoma, indicating substantial survival benefits for patients. IDEAYA Biosciences and Roche are set to collaborate on a clinical trial evaluating IDE892 in combination with RG6505 for the treatment of pancreatic cancer. This collaboration includes an upfront payment and potential milestone payments to IDEAYA Biosciences.
On the medical device front, OrthAlign, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lantern ASC system. This handheld orthopedic navigation solution is designed to provide precision in surgical procedures at a lower cost and with less complexity than existing robotic systems. Separately, Photocure ASA has completed the acquisition of Vesica Health Inc., a U.S.-based precision diagnostics company, a move intended to strengthen Photocure's presence in the bladder cancer diagnostics market.
Further advancements include Mammotome, a subsidiary of Danaher, obtaining CE mark approval in Europe for its HydroMARK Plus breast biopsy site markers. These markers feature proprietary hydrogel technology aimed at improving stability and visibility during breast care procedures. In the realm of research and development, Bio Ascend, a Vaniam Group company, has taken over the stewardship of the iwNHL and iwMyeloma workshops from World Health Communications, with the goal of fostering their growth and development. Additionally, Exigent Research Network, which focuses on oncology research opportunities for independent practices, has appointed Nina Chavez as its new Senior Vice President of Growth, tasked with expanding the company's national reach and services. The Conquer Cancer, the ASCO Foundation, presented the 2026 Young Investigator Awards, funded by Vaniam Group and Women Leaders in Oncology, to physician-scientists Nia Beckley and Jordyn Silverstein.
The European Commission has granted approval for Amgen's Imdyetra, a new treatment option for patients with extensive-stage small cell lung cancer. This decision follows Phase 3 trial results that demonstrated a significant 40% reduction in the risk of death when compared to standard chemotherapy, offering a new therapeutic avenue for this patient population.