ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

Recently, HHS Secretary Robert F. Kennedy Jr. posted a video montage featuring himself shirtless in jeans, working out with Kid Rock. The duo is in a blue-lit grotto with a cold plunge and sauna. Set to Kid Rock’s “Bawitdaba” and intercut with a selection of patriotic imagery, the video ends with the two men in a hot tub, chugging what appears to be milk.

April 03, 2026

Vol.52 No.13

By Claire Marie Porter

Guest Editorial

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies.

April 03, 2026

Vol.52 No.13

By Nicholas Richardson

Cancer Policy

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

President Donald Trump has imposed a 100% tariff on drugmakers that have not struck a deal with the president to lower the U.S. drug prices of patented pharmaceutical products and ingredients.

April 03, 2026

Vol.52 No.13

By Claire Marie Porter

Clinical Roundup

IMNN-001 improves median OS by over 14 months in newly diagnosed advanced ovarian cancer, phase II study shows

Adding IMNN-001, a DNA-mediated immunotherapy, to standard-of-care treatment improved median overall survival by 14.7 months in patients with newly diagnosed advanced ovarian cancer, final clinical data from the OVATION 2 study shows.

April 03, 2026

Vol.52 No.13

Drugs & Targets

FDA approves Tecartus for r/r mantle cell lymphoma

FDA granted full approval to Tecartus (brexucabtagene autoleucel), Kite’s CAR T-cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma.

April 03, 2026

Vol.52 No.13

Drugs & Targets

FDA approves Ponlimsi to increase bone mass, including for breast and prostate cancer patients

FDA has approved Ponlimsi (denosumab-adet) as a biosimilar to Prolia.

April 03, 2026

Vol.52 No.13

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

YOU MAY BE INTERESTED IN

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

IMNN-001 improves median OS by over 14 months in newly diagnosed advanced ovarian cancer, phase II study shows

FDA approves Tecartus for r/r mantle cell lymphoma

FDA approves Ponlimsi to increase bone mass, including for breast and prostate cancer patients

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ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

YOU MAY BE INTERESTED IN

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside downThe Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters mostDraft guidance consolidates trial design updates for developers

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

IMNN-001 improves median OS by over 14 months in newly diagnosed advanced ovarian cancer, phase II study shows

FDA approves Tecartus for r/r mantle cell lymphoma

FDA approves Ponlimsi to increase bone mass, including for breast and prostate cancer patients

Never miss an issue!

Login

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers