EMA十月CHMP会议建议批准六款新药并扩展五款适应症，涉及礼来、辉瑞、强生、Ionis、再生元、Revolution Medicines与Ascendis

An expert panel of the EU drug regulator endorsed six new medicines and five label expansions for approval during its October 2026 meeting held this week, marking regulatory wins for companies including Eli Lilly ( LLY ), Pfizer ( PFE ), and Revolution Medicines ( RVMD ). Lilly The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on the Indiana-based pharma giant’s weight loss pill, Foundayo (orforglipron), for weight management and type 2 diabetes in adults. Pfizer The New York-based pharma giant received a positive CHMP opinion that recommended an indication extension for its breast cancer therapy Tukysa. The tyrosine kinase inhibitor is already available in the EU as a third-line option for HER2-positive breast cancer in combination with capecitabine, another antitumor medication, and trastuzumab marketed by Roche ( RHHBY ) as Herceptin. The decision endorses a variation for Tukysa marketing authorization to include its use in combination with trastuzumab and Roche’s ( RHHBY ) Perjeta for adults with unresectable or metastatic HER2-positive breast cancer who have undergone first-line chemotherapy. Johnson & Johnson The New Jersey-based drugmaker ( JNJ ) received a positive CHMP opinion that recommended an indication extension for its cancer therapy Talvey. The endorsement calls for its use as a second-line combination therapy for adults with relapsed or refractory multiple myeloma, a bone marrow cancer. Talvey is already available in the region under the conditional marketing authorization from the European Commission as a single agent for adults with RRMM who have received at least three prior therapies. Ionis Pharma CHMP issued a positive opinion recommending a label expansion for Ionis Pharmaceuticals’ ( IONS ) lipid-lowering agent Tryngolza (olezarsen), which is marketed by the company and Swedish firm Sobi ( BIOVF ) ( SWOBY ) in the EU. The RNA-targeted therapy was endorsed as an adjunct to diet with other lipid-lowering agents for adults with severe hypertriglyceridemia. The decision, which, according to Ionis ( IONS ), came ahead of its previously anticipated timeline, paves the way for the EC to make a final decision on the recommendation in Q4 2027. Regeneron The Tarrytown, New York-based company announced that the CHMP issued a positive opinion regarding an alternative dosing schedule for its cancer therapy, Libtayo (cemiplimab) across all six approved indications. The decision supports an extended dosing regimen of higher-dose Libtayo (700 mg), reducing its dosing frequency to every six weeks from every three weeks after the initial 12 weeks of therapy. Additionally, the CHMP experts have backed a 15- to 30-minute infusion option for Libtayo 350 mg if the first infusion at this dosing level administered over 30 minutes is well tolerated. The EC is expected to make a final decision on the recommendation in the coming months. Revolution Medicines The cancer drugmaker announced on Thursday that the CHMP issued a positive opinion on its oral RAS inhibitor, Rasonque (daraxonrasib), as a second-line option for adults with metastatic pancreatic adenocarcinoma. The decision is backed by data from the company’s RASolute 302 Phase 3 trial, which met all primary and key secondary endpoints in both the RAS G12 mutant patients and the intent-to-treat population. Pending a final decision from the European Commission, the once-daily oral tablet will be available across all 27 EU member states as well as  Iceland, Norway, and Liechtenstein. Ascendis Pharma This week, CHMP also issued a positive opinion recommending marketing authorization for the Danish drugmaker’s ( ASND ) rare disease therapy Yuviwel (navepegritide) for children with achondroplasia, the most common form of short-limb dwarfism.