publication date: Feb. 28, 2020

ODAC: Thumbs up for Eli Lilly’s Cyramza, thumbs down for STEBA’s Tookad

By Paul Goldberg

The FDA Oncologic Drugs Advisory Committee Feb. 26 voted down a vascular-targeted photodynamic therapy for early-stage, low-risk prostate cancer and, in a narrow vote, recommended approval for a combination of a VEGF receptor 2 antagonist and an EGFR-targeting tyrosine kinase inhibitor for front-line treatment of EGFR-positive non-small cell lung cancer.

In a 13:2 vote, ODAC shot down Tookad (padeliporfin di-potassium) for the treatment of patients with localized prostate cancer, as a means to delay or prevent their moving to radical prostatectomy or radiation therapy. The agent is sponsored by Steba Biotech, S.A.

In a 6:5 vote, ODAC recommended approval for a supplemental biologics license application for a combination of Cyramza (ramucirumab) for intravenous use in combination with Roche’s Tarceva (erlotinib), for first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations. Cyramza is sponsored by Eli Lilly and Co.

 

FDA’s oncology office usually convenes its clinical advisory committee to air out its “interesting” cases, and, of course, anyone developing a cancer drug would take a “no-brainer” over “interesting” any day.

The Feb. 26 session of ODAC offered two highlights:

In discussion of Tookad, ODAC’s temporary member Patrick Walsh, University Distinguished Service Professor Emeritus, at James Buchanan Brady Urological Institute, at Johns Hopkins Hospital delivered an incredulous why-the-hell-are-we-here critique of the therapy.

The Cyramza application triggered “a Pazdur moment,” in this case, a discussion of standards for approval of therapies which do not … Continue reading ODAC: Thumbs up for Eli Lilly’s Cyramza, thumbs down for STEBA’s Tookad

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