FDA grants Priority Review to MCNA

FDA granted priority review for MCNA, developed by Telesta Therapeutics Inc.

The FDA completed its initial review of Telesta’s biologics license application and accepted it for filing. The agency set Feb. 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.

MCNA is a biologic therapy developed to treat high-risk, non-muscle invasive bladder cancer patients who are refractory to or relapsing from front-line therapy, and is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects.

MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin therapy. The efficacy, duration of responses and safety data from MCNA’s phase III trial was recently published in The Journal of Urology.

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FDA grants Priority Review to MCNA

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FDA grants Priority Review to MCNA

YOU MAY BE INTERESTED IN

Anthony Letai reflects on Year One as NCI Director: “The NCI is in business”

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer PanelThe cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

ASCO Genitourinary Cancers Symposium: Pioneering breakthroughs, optimizing patient outcomes

Never miss an issue!

Login

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer Panel
The cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”