Gilead's Yescarta eyes first to move up lymphoma ladder in Europe amid busy week at EMA

After leading the CAR-T field to a first-in-class FDA nod for earlier treatment of certain blood cancers, Gilead Sciences’ Yescarta looks on track to cross the finish line first in EU, too.

Yescarta’s proposed use as a second-line treatment for diffuse large B-cell lymphoma and high-grade B-cell lymphoma has received backing from drug reviewers at the European Medicines Agency. Similar to the drug’s FDA nod, the recommendation covers patients who either don’t respond to initial treatment or relapse fast within 12 months.

If approved, Yescarta would be the first CAR-T therapy in Europe for second-line treatment of lymphoma. Its in-class rival, Bristol Myers Squibb’s Breyanzi, has a similar application, which the EMA accepted about three months ago.

Back in June, Breyanzi secured a surprisingly broad second-line indication from the FDA less than three months after Yescarta’s first-in-class approval. While both Bryenazi and Yescarta were tested in phase 3 trials in patients who were suitable for stem cell transplants, the FDA gave the BMS drug an extra line, allowing it to be used for transplant-ineligible patients with refractory or relapsed disease without any restriction on time to relapse.

That additional label language is based on findings from a phase 2 trial. But according to BMS, the application currently under review at the EMA only covers people who are candidates for stem cell transplants.

Meanwhile, the EMA’s Committee for Medicinal Products for Human Use (CHMP) also recommended an approval for a CAR-T rival in the CD19-targeted antibody-drug conjugate Zynlonta by a collaboration between Sobi and ADC Therapeutics. The drug is now headed to the European Commission for a potential nod in previously treated DLBCL.

In addition, CHMP also recommended initial approvals of drugs from Takeda, Sanofi, Agios and others.

For Takeda, the CHMP adopted a positive opinion for Livtencity for post-transplant cytomegalovirus that's refractory to at least one prior therapy. The endorsement puts Livtencity on track to an eventual European Commission approval a year after its U.S. FDA nod.

But as Takeda has previously announced, the company has withdrawn a European application for Exkivity in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations after reviewers requested more data. The company is now planning a filing in 2024 for newly diagnosed disease based on expected phase 3 data.

In addition to Takeda, Hutchmed also decided to withdraw an application for Sevsury, or surufatinib, in neuroendocrine tumors. The EMA raised several concerns around Hutchmed’s data package and indicated an approval was unlikely at this point. The European regulator raised some similar questions as their FDA counterpart did in rejecting the drug back in May.

Back to the winners’ side, Sanofi got CHMP backing for two products—one for AstraZeneca-partnered RSV prevention med Beyfortus in infants, and the other for Enjaymo in the rare blood autoimmune disorder cold agglutinin disease.

The agency also greenlit Amryt Pharma’s Mycapssa and Agios’ Pyrukynd, both for rare conditions.