The U.S. Food and Drug Administration placed a partial clinical hold on the TakeAim lymphoma study while the biotech company Curis provides further data to better understand safety and efficacy questions.

AstraZeneca

AstraZeneca will showcase the company’s early oncology portfolio that it believes has the potential to transform the oncology treatment landscape at the upcoming American Association for Cancer Research (AACR) conference. 

Legend Biotech’s clinical trial of the company’s candidate drug for relapsed or refractory T-cell lymphoma was placed on hold effective February 11 after some issues were raised on the first patient dosed. 

FDA

The U.S. Food and Drug Administration is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib), which is indicated for two types of lymphoma.

Incyte Corporation withdrew the New Drug Application (NDA) for the company’s candidate drug for various types of lymphoma.

Gilead

The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.

Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).

Bristol Myers Squibb is withdrawing the biopharmaceutical giant’s Istodax from the market after recent trials showed that the peripheral T-cell lymphoma drug did not achieve primary efficacy endpoint.

China welcomed the first CAR T-cell therapy in the country following approval from the National Medical Products Administration. 

Regeneron Pharmaceuticals said on May 17 the company was resuming the enrollment of patients in two studies testing the experimental lymphoma drug odronextamab after the U.S. Food and Drug Administration agreed to lift a partial clinical hold.