![]() ![]() Its Phase 1 trial showed a complete remission rate of 89% in ALL. The first half of 2018 is the new launch date for the Juno therapy for acute lymphoblastic leukemia (ALL).īased on very preliminary data, the drug, JCAR015, appears to be extremely effective. But Juno's CEO Hans Bishop said the need to modify the trial to avoid toxic effects would delay the filing and hoped-for launch. The FDA had put a temporary hold on the trial, but it lifted it a few days later, when Juno modified the trial.īefore the deaths, Juno's goal was accelerated FDA approval in 2017, and launch immediately following. Juno quickly linked the tragic fatal reactions to chemo agent fludarabine, used in the CAR-T pre-conditioning regimen. The issue was the deaths of several trial participants from neurotoxicity. Other CAR-T companies got caught up in the volatility and promptly tanked. In early July, Juno's stock took a wild, 180-degree turn after a critical study for its lead CAR-T therapy was halted. ![]() Juno is behind on its launch date, but it has strong data Here's a closer look at why investor skepticism (as well as some guarded optimism) could be in order. Juno's candidate therapy's Phase II trial is still recruiting, and data is very slim. Kite reportedly will base its FDA filing on a Phase II data set of 51 patients, followed for three months. The FDA will be making its decision based on data that isn't robust for either company. The pot of gold at the end of the rainbow is huge - peak sales estimates of CAR-T therapies run up to $10 billion annually. But these therapies are highly unusual, they have a nasty track record for toxicity, and it's hard to know how regulators will view them. ![]() ![]() Follow her on Twitter at source: Getty Images.Īs Juno Therapeutics ( NASDAQ:JUNO) and Kite Pharma (NASDAQ: KITE) ramp up for a potential 2017 or early 2018 launch of their lead CAR-T therapies, investor caution is advised. Although the companies' cancer-killing immune cell therapies represent an exciting leap forward in cancer treatment, both companies are approaching pivotal FDA decisions, which could make or break these stocks. With a 20-year background as a former medical technology and management consultant, as well as a cancer survivor, Cheryl has a unique perspective on health care. Cheryl has six books published, and currently resides in Hawaii with her husband, her daughter and two dozen surfboards. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |