EMA approves two new drugs – J&J’s BCMA CAR-T for multiple myeloma, AstraZeneca’s Evusheld – plus 5 label extensions

The European Medicines Agency’s CHMP on Friday advised two new drugs for approval, AstraZeneca’s Evusheld to help prevent Covid-19, and Johnson & Johnson’s new BCMA CAR-T fourth-line treatment for multiple myeloma.

Approved in the United States about four weeks ago, J&J and Legend’s new drug, sold as Carvykti, will rival BMS and bluebird bio’s BCMA CAR-T Abecma, although Legend and Janssen say some long-term data suggest they might have an advantage. While in the EU the Commission has yet to approve Carvykti for full approval, CAR-T is launching in the US at $465,000, according to Scott White, J&J’s group president for pharmaceuticals in North America. , which is higher than Abecma’s price of $419,500. label.

“The positive CHMP opinion reinforces the potential of cilta-cel for patients with multiple myeloma worldwide,” Legend CEO Ying Huang said in a statement. “We look forward to the EMA for the potential for European Commission approval in the future and continued progress in the development of cilta-cel.”

In the meantime, the CHMP has also sign on AstraZeneca’s prophylactic treatment for Covid-19, known as Evusheld, but the data came from a trial before the latest Omicron wave.

Although the FDA double the dose for Evusheld recently, the EMA is sticking to the lower dose, but it “will evaluate the data in the coming weeks to assess whether an alternative dosing regimen might be appropriate for the prevention of COVID-19 resulting from emerging variants “.

In the meantime, the CHMP has also recommended five new label extensions for:

1. Merck’s Keytruda in Metastatic Cervical Cancer (FDA) approval came last October)
2. Another indication of graft versus host disease for Novartis’ Jakavi (FDA approval arrived last September)
3. Novartis’ Kymriah for the third-line treatment of adults with relapsed or refractory follicular lymphoma (priority review in the USA)
4. Roche’s Polivy for previously untreated diffuse large B-cell lymphoma (FDA expedited approval in June 2019)
5. Ipsen’s Cabometyx for differentiated thyroid carcinoma (FDA approval last September)