A fresh stack of approval and expansion recommendations has emerged following this month's meeting of European drug regulators.
On the heels of its November confab, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has vouched for the approval of three new drugs, two biosimilars and two generics. The regulator also recommended extensions to the labels of 11 already-approved medicines in Europe and made a cautionary note to physicians about a potential interaction between GLP-1s and oral contraceptives.
Among the most notable recommendations was a positive opinion for Aumseqa, which means the non-small-cell lung cancer treatment's commercial license could be reinstated after the European Commission revoked its EU marketing authorization in September.
After a long and winding four-year approval process, the Hansoh and SFL Pharma partnered drug was initially recommended by the CHMP a year ago in November 2025 and approved by the European Commission in February.
But in September, the EC pulled the authorization, determining that Aumseqa’s original application from 2022 violated data protection rules by referencing AstraZeneca’s data for competitor product Tagrisso. The EC’s decision was prompted by a lawsuit levied against the agency by AstraZeneca in the EU’s General Court.
While Aumseqa is yet to generate sales outside of China, it has the potential to be a meaningful challenger to Tagrisso, which currently stands out as the world’s best-selling EGFR inhibitor with nearly $3.8 billion in sales in the first half of 2026.
AstraZeneca saw its own win at the CHMP this week, securing a positive recommendation for its first-in-class blood pressure med, Baxfendy, as a treatment for insufficiently controlled hypertension. AZ came to own the novel aldosterone synthase inhibitor (ASI) through its $1.3 billion buyout of CinCor Pharma in 2023, and it secured FDA approval for the drug earlier this year.
The drug is a core part of AZ’s plans to reach $80 billion in sales by 2030. The drugmaker has hinted that peak sales for Baxfendy could reach upwards of $5 billion.
Last up on the CHMP’s new drug recommendations, Zybrivo received a positive opinion for non-squamous non-small cell lung cancer. The drug, which was previously co-developed by Innovent Biologics and Eli Lilly, was approved in China way back in 2018, but its path to global approval has been rocky.
Lilly originally held global rights to the drug outside of China, but after the FDA rejected Zybrivo’s application in 2022 due to China-only data and an outdated control group, the drugmaker returned non-China rights back to Innovent. Innovent’s subsidiary Fortvita Biologics is now carrying the EU application forward and with the CHMP’s decision in hand, an okay from the EC is pending. The cancer drug likely still has an uphill battle ahead as it enters a market dominated by Merck heavyweight Keytruda.
Outside new drug applications, Merck scored three recommendations for label expansion in the EU.
The agency recommended that Merck's monoclonal antibody Enflonsia be expanded to include children up to 24 months old who are at increased risk of respiratory syncytial virus (RSV). And Welireg, Merck’s first-in-class oral HIF-2α inhibitor, was recommended alongside lenvatinib (Lenvima) in patients with advanced clear cell renal cell carcinoma that has progressed following prior therapy that included a PD‑(L)1 inhibitor. Meanwhile, Merck’s type 2 diabetes med, Steglatro, was recommended alongside diet and exercise in children 10 and up whose diabetes is not adequately controlled.
Meds from Gilead, Pfizer, ViiV and Roche also made the cut and secured CHMP expansion recommendations this week.
Beyond new meds and expansions, the CHMP dug into a potential side effect of leading diabetes GLP-1 injection Mounjaro from Eli Lilly. The regulator voted to adopt an official communication to providers about Mounjaro’s potential effect on the reliability of oral contraceptives.
Contraception is recommended for women who are on Mounjaro and can become pregnant, but little is known about the drug’s potential interactions with oral contraceptives. As such, the agency said women taking Mounjaro and an oral contraceptive are advised to either switch to a non-oral contraceptive or to add a barrier method of contraception for 4 weeks after starting Mounjaro and 4 weeks after every dose increase.
Following the review, a spokesperson from Lilly told Fierce that the company "is updating the European product information for Mounjaro® (tirzepatide) with revised contraception guidance for women of childbearing potential." The drugmaker clarified that this is a "precautionary update" on contraception for patients starting Mounjaro and after each dose increase.
This advisement, along with the new approval and label expansion recommendations from the CHMP, are now en route to the EC for a final sign-off.
Editor's note: This story has been updated to include comment from an Eli Lilly spokesperson.