FDA approves Rezlidhia for R/R AML with a susceptible IDH1 mutation

Citing need for “more conversations” on menthol, White House scuttles move to ban the flavor favored by Black smokers

The Biden administration has—for the second time—delayed the decision on a proposed FDA rule that would ban menthol cigarettes and all flavors in cigars.

May 03, 2024

Vol.50 No.18

By McKenzie Prillaman

Clinical Roundup

Lower MRD prior to HCT associated with better outcomes in FLT3-ITD AML

Patients in remission after being treated for a high-risk blood cancer are likely to have better outcomes if no trace of the cancer is detectable before the patients receive donor blood cells.

May 03, 2024

Vol.50 No.18

Drugs & Targets

FDA rule focuses on the safety and effectiveness of LDTs

FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.

May 03, 2024

Vol.50 No.18

Drugs & Targets

FDA issues additional draft guidance on eligibility criteria for cancer drug clinical trials

FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.

May 03, 2024

Vol.50 No.18

Regulatory News

ODAC unanimously upholds MRD as early endpoint across all settings in multiple myeloma

In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.

April 26, 2024

Vol.50 No.17

By Jacquelyn Cobb