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Kite CAR-T med seen passing FDA, prepped for fast launch

August 8, 2017

The FDA has evidently learned all it wants at this point from its outside oncology experts on CAR-T. Kite Pharma’s closely-watched CAR-T drug axi-cel is getting a pass on an adcomm meeting, which may signal a quick thumbs up from regulators.

Kite $KITE execs think so, saying today that they will be fully launch-ready by September in case an early OK comes through. And that bullish stance earned a 7% boost to its share price today.

In a Q2 call with analysts Tuesday morning, Kite R&D chief David Chang told analysts the FDA had notified the biotech that regulators will not be organizing a panel review with outside experts for axi-cel. Novartis was first up in July, gaining unanimous backing for CTL019 from an FDA panel in the leadup to an early-October PDUFA date.

Novartis had been seen as the clear front-runner in the race to get on the market first, but with the FDA finish line blurring, they may now both launch almost simultaneously.

“We are extremely encouraged by the recent advisory committee meeting” for Novartis, Chang said, which he sees as a likely harbinger for Kite. “The FDA has informed us that they will not schedule an advisory committee meeting” for axi-cel. This follows an FDA inspection of its manufacturing facility and its treatment centers in the lead-up to an accelerated review and final decision.

Kite faces a November 29 deadline for its marketing decision from the FDA, but the company says it’s ready to start making the personalized therapy and start shipping almost immediately.

These pioneering CAR-T drugs offer a proverbial game-changing approach in treating blood cancers. T cells are extracted from patients and armed with chimeric antigen receptors, turning them into cancer fighters that are pumped into a potent mix that is then infused into the patient.

To say that Kite has been anticipating the launch for several years now is an understatement. Axi-cel is widely viewed as a blockbuster in the making, and Kite has been building manufacturing operations and a commercial group with plans to hit the ground running, hitting a vein-to-vein turnaround time on this therapy of 17 days. In the meantime, its R&D group today signaled that they have filed for an IND to start Phase I work on KITE-585, its next-gen approach that targets BCMA.

“With the anticipated events on the horizon for the remainder of 2017,” said CEO Arie Belldegrun, “the potential for CAR-T to become one of the most powerful anti-cancer agents for certain patients may finally be realized.”

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