Pharmaceutical Market Europe • April 2026 • 8
NEWS
AstraZeneca’s Imfinzi approved in EU for early gastric and gastro-oesophageal cancers
Imfinzi (durvalumab), in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel), has received EU approval.
The perioperative immunotherapy was approved to treat adult patients with resectable, early-stage and locally advanced gastric and gastro-oesophageal junction (GEJ) cancers.
Nearly one million people are diagnosed with gastric cancer each year, the fifth leading cause of cancer deaths globally.
The approval is based on positive results from the MATTERHORN phase 3 trial, and follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
In an interim analysis, patients who received the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus with chemotherapy alone.
After a year, around 78.2% of patients treated were event-free, compared to 74.0% in the comparator arm. After two years, the results showed around 67.4% of patients treated were event-free, compared to 58.5% in the comparator arm.
Overall survival (OS) rates showed an improvement of 22% compared to chemotherapy alone, with around 69% of patients surviving for three years compared
to 62% in the comparator arm.
Novo Nordisk’s Awiqli approved as once-weekly insulin for type 2 diabetes patients
Novo Nordisk’s Awiqli (insulin icodec) has been approved by the US FDA as the first and only once-weekly, long-acting basal insulin for adults with type 2 diabetes (T2D).
Based on results from the ONWARDS phase 3a trial, the approval provides a new treatment solution that fits around patients’ routines and preferences.
Around 2,680 adults with uncontrolled T2D took part in the four randomised, active-controlled, treat-to-target ONWARDS trials.
In the trials, the once-weekly Awiqli injection was used in combination with a mealtime insulin or common oral anti-diabetic agents and/or GLP-1 receptor agonists.
Awiqli was compared to daily basal insulin, demonstrating efficacy in the primary endpoint of HbA1c reduction and a safety profile consistent with the daily basal insulin class.
Injected once a week on the same day, Awiqli is expected to launch in the US in the second half of 2026. The treatment has also received approval in 13 countries and the EU.
Mike Doustdar, president and CEO of Novo Nordisk, said: “As the first FDA-approved, once-weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option.”
BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin’s lymphoma
Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved for two new classical Hodgkin lymphoma (cHL) indications in the US and the EU.
The US FDA has approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat patients 12 years and older with previously untreated stage 3 or 4 cHL.
In the EU, approval has been granted by the European Commission (EC) for Opdivo in combination with brentuximab vedotin to treat patients between five and 30 years of age with relapsed or refractory cHL who have already received one prior line of therapy.
SWOG 1826, a phase 3 study on which the US FDA based its approval, evaluated Opdivo in combination with AVD in patients aged 12 years and older with previously untreated stage 3 or 4 cHL.
The study showed a 58% reduction in the risk of disease progression or death, showing a statistically significant improvement in the primary endpoint of progression-free survival (PFS) for patients who received Opdivo in combination with AVD.
Despite progress in frontline therapy, advanced-stage HL still carries a substantial risk of relapse, highlighting the need for innovative approaches.
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