New Eli Lilly, Roche meds win backing from EU committee, but Clovis' Rubraca nixed in late-stage ovarian cancer

Six weeks after Clovis voluntarily discontinued its third-line use of ovarian cancer drug Rubraca in the United States for safety reasons, Europe’s Committee for Medicinal Products for Human Use has concurred with the action.

The CHMP recommends that Rubraca not be used for cancers of the ovaries, fallopian tubes or peritoneum with a BRCA mutation after exhausting platinum-based chemotherapy options. Along with that action, the committee endorsed a handful of new drugs for approval, including several from Big Pharma companies.

Clovis' Rubraca, approved by the FDA in 2016, came under scrutiny when a postmarketing trial linked the drug to an increased risk of death over chemo in third- or later-line use even though it stalled disease progression.

The CHMP review came at Clovis’ request last month. Rubraca still is cleared for use in patients with BRCA mutant, metastatic castration-resistant prostate cancer and as a maintenance treatment for recurring ovarian cancer.

Another recommendation from CHMP came for expanding the use of Bavarian Nordic's smallpox vaccine to monkeypox to address the rise in cases in Europe. Imvanex, which was sanctioned in Europe for smallpox in 2013, also has been blessed by CHMP to protect against disease caused by vaccinia virus, which leads to symptoms similar to, but milder than those of smallpox.  

Known as Jynneos in the U.S., the vaccine was approved by the FDA for use against smallpox and monkeypox in 2019. Early this month, the U.S. agreed to buy 2.5 million shots, which will bring the national stockpile of the vaccine to more than 4 million.

Meanwhile, it was a busy week for CHMP as the group rendered positive recommendations on 11 more new drugs, bringing its total checkmarks for the year to 58.

The CHMP signed off on Eli Lilly’s highly anticipated type 2 diabetes treatment Mounjaro, which was endorsed by the FDA two months ago. A nod by the European Commission would open the treatment up to 30 million patients who suffer from the condition in Europe and set up a battle with Novo Nordisk’s blockbuster Ozempic.

Another drug projected to have a big impact, Roche’s Vabysmo, also got a thumbs up from the CHMP for the treatment of adults with macular degeneration and diabetic macular edema. With a longer-acting, dual pathway formula, Vabysmo—which was approved in the U.S. in January—presents an attractive option to Bayer and Regeneron’s mega-blockbuster Eylea as it requires fewer doctors’ visits for most patients.

Also getting a positive opinion from CHMP was Bristol Myers Squibb’s Opdualag for skin cancer that can’t be removed by surgery. The drug—a combination of PD-1 inhibitor Opdivo and LAG-3 blocking antibody relatlimab—was sanctioned by the FDA in March.

Two multiple myeloma drugs were blessed by the CHMP as well—Johnson & Johnson’s bispecific antibody Tecvayli and hybrid medicine Talidomide Lipomed.

Tecvayli is an interesting case as it is progressing toward the market quicker in Europe than in the U.S. J&J applied for FDA approval in December of last year.

The CHMP recommendation is for a conditional approval, which must be renewed annually. The designation can be applied to drugs that have yet to be proven in trials but may provide severely ill patients with a last-chance option. Tecvayli is for use as a fourth-line treatment.

Another drug getting a thumbs up from CHMP was Aurinia and Otsuka's Lupkynis, a treatment for active lupus nephritis, which was approved in the U.S. 18 months ago.

Also among the drugs receiving nods from the CHMP were Alynlam’s Amvuttra for transthyretin-mediated amyloidosis, a hereditary nerve-damage condition, Pfizer’s Celdoxome for the treatment of a variety of cancers, AstraZeneca and Amgen’s asthma treatment Tezspire and BridgeBio and Affiliate’s Nulibry for the ultra-rare molybdenum cofactor deficiency type A.  

In Europe, after CHMP endorses a pharmaceutical product, the European Commission typically follows up with an official nod.