Pharmaceutical Market Europe • December 2025 • 6
NEWS
AstraZeneca’s Imfinzi combination approved by FDA for GEJ cancers
AstraZeneca’s Imfinzi (durvalumab), in combination with standard of care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel), has been approved by the US FDA to treat adult patients with resectable, early-stage and locally advanced gastric and gastro-oesophageal junction (GEJ) cancers.
The approval follows a Priority Review from the FDA, and is based on results from the MATTERHORN phase 3 trial, which enrolled participants in 176 centres across 20 countries.
Final results showed that the Imfinzi/FLOT combination reduced the risk of death by 22% compared to chemotherapy alone. An estimated 69% of Imfinzi/FLOT patients were alive at three years, compared with 62% in the FLOT-only arm.
Gastric cancer is the fifth most common cancer in the world and the fifth-highest cause of cancer deaths. Recurrence and relapse are common in patients with resectable gastric cancer and survival rates remain poor, with less than half of gastric cancer patients alive at five years.
In combination with chemotherapy, Imfinzi is already approved to treat a number of different cancers, including both small cell and non-small cell lung cancer.
Novartis’ Itvisma receives approval from FDA for SMA treatment
Novartis’ Itvisma (onasemnogene) has been approved by the US FDA to treat spinal muscular atrophy (SMA) in children aged two years and older, teenagers and adults with a confirmed mutation in the survival motor neuron 1 (SMN1) gene.
SMA is a rare, genetic neuromuscular disease caused by a mutated or missing SMN1 gene.
Since the SMN1 gene is directly responsible for producing the SMN protein needed for muscle function, problems with this gene can cause progressive and debilitating muscle weakness. Around 9,000 people in the US currently live with SMA.
Itvisma is designed to provide a functional copy of the SMN1 gene, thereby boosting SMN protein expression and improving motor function. While many other available SMA therapies need to be administered regularly, Itvisma can be given as a single injection that does not need to be adjusted for age or body weight.
The approval of Itvisma is based on data from two phase 3 studies, in which the treatment showed statistically significant improvements in motor function and stabilisation of motor abilities. These effects were sustained over 52 weeks of follow-up.
Pfizer’s Padcev combination gets FDA approval for bladder cancer
The US FDA has approved Pfizer’s Padcev (enfortumab), in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase), to treat certain patients with bladder cancer.
The approval follows the publication of results from the phase 3 EV-303 clinical trial. The trial found that the probability of survival at two years was 79.7% for patients who received the combination, relative to 63.1% for patients treated with surgery only. It also found no new safety signals associated with the combination treatment.
The Padcev-Keytruda combination has been approved as a perioperative treatment for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
Bladder cancer is the ninth most common cancer worldwide, affecting more than 614,000 people each year globally, with an estimated 85,000 of those living in the US. MIBC makes up around 30% of all bladder cancer cases. Neoadjuvant cisplatin-based chemotherapy followed by surgery has been shown to prolong survival in patients with MIBC, but up to half of MIBC patients are ineligible to receive cisplatin, demonstrating the need for new treatments.
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