The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.
Roche’s Polivy is now approved as an earlier line of treatment for patients who have diffuse large B-cell lymphoma. Accelerated approval of the drug in 2019 had made the drug a third treatment option for patients with advanced cases of this type of blood cancer.
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After some setbacks and delays, the FDA approved Bristol Myers Squibb’s Breyanzi for certain lymphomas. It’s the fourth CAR T treatment to win the regulatory nod and the first under a new regenerative medicine designation.
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.
The German drugmaker plans to submit its data package for FDA approval by the end of the year, with potential approval next year. The package will include a synthetic control arm comprising real-world data.
The drug, Polivy, was developed using antibody-drug conjugate technology in-licensed from Seattle Genetics. It received accelerated approval Monday for diffuse large B-cell patients relapsed or refractory after at least two prior therapies.
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A spokesperson for the company noted that patients in the Phase II L-MIND trial of the CD19-targeting drug tafasitamab would be too old and frail to be candidates for CAR-T therapies.
Still, despite costs largely in line with the therapy's benefits, the study's author and another expert said reimbursement models have not kept up and need improvement.
The decision is not final, but the Swiss drugmaker's shares were down 1 percent in morning trading. NICE reached a similar decision last month on competitor Gilead's Yescarta.