Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

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

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FDA issues additional draft guidance on eligibility criteria for cancer drug clinical trials

FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.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

Conversation with The Cancer Letter

Clearing the path for MRD as early endpoint in multiple myeloma

Sylvester’s C. Ola Landgren: “I was convinced that this is really the way to go”

FDA approves Anktiva for non-muscle-invasive bladder cancer

FDA has approved ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

April 26, 2024

Vol.50 No.17

Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

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

FDA rule focuses on the safety and effectiveness of LDTs

FDA issues additional draft guidance on eligibility criteria for cancer drug clinical trials

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

Clearing the path for MRD as early endpoint in multiple myeloma

FDA approves Anktiva for non-muscle-invasive bladder cancer

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