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

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Amid deepening controversy, Vinay Prasad, FDA’s top clinician and scientist, and director of its Center for Biologics Evaluation and Research, will be leaving the agency.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter

Regulatory News

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.

FDA approves leucovorin for cerebral folate deficiency

FDA has approved leucovorin calcium tablets (Wellcovorin), expanding its use for the treatment of cerebral folate deficiency in adult and pediatric patients.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter

Clinical Roundup

Phase III persevERA study of giredestrant combination in ER-positive advanced breast cancer does not meet primary objective

The phase III persevERA Breast Cancer study, evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed.

March 13, 2026

Vol.52 No.10

Clinical Roundup

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to positive interim phase III results from the SUCCESSOR-2 study.

March 13, 2026

Vol.52 No.10

Clinical Roundup

Nutrition therapy extends survival by 34% in stage 4 pancreatic cancer patients, clinical trial shows

Medically supervised, individualized nutrition therapy—long proven effective in reversing metabolic diseases like type 2 diabetes and obesity—shows promise in extending survival in patients with metastatic pancreatic cancer when used alongside chemotherapy, according to data from a randomized, controlled phase II clinical trial.

March 13, 2026

Vol.52 No.10

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

YOU MAY BE INTERESTED IN

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA approves leucovorin for cerebral folate deficiency

Phase III persevERA study of giredestrant combination in ER-positive advanced breast cancer does not meet primary objective

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Nutrition therapy extends survival by 34% in stage 4 pancreatic cancer patients, clinical trial shows

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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

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA approves leucovorin for cerebral folate deficiency

Phase III persevERA study of giredestrant combination in ER-positive advanced breast cancer does not meet primary objective

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Nutrition therapy extends survival by 34% in stage 4 pancreatic cancer patients, clinical trial shows

Never miss an issue!

Login

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”