Galapagos (GLPG) stock surged Monday after the Food and Drug Administration cleared the biotech company to begin testing its cancer drug in people. RBC Capital Markets analyst Brian Abrahams says this is an important step for furthering Galapagos' point-of-care model for CAR-T drugs. CAR-T drugs involve removing a patient's immune cells and then genetically modifying them to find and destroy cancer cells. 

The US Food and Drug Administration (FDA) has granted clearance for Galapagos’ investigational new drug (IND) application to commence the Phase I/II ATALANTA-1 study of GLPG5101 for relapsed/refractory non-Hodgkin lymphoma (r/r NHL).

Kyowa Kirin and MEI Pharma have posted more midphase data on their oncology candidate zandelisib, confirming the efficacy seen in an earlier trial of the PI3K delta inhibitor. But with the FDA raising the bar for the asset, the companies need an ongoing phase 3 to deliver to get the prospect to the U.S. market.

Gene editing biotech Precision BioSciences is touting phase 1/2 results as proof it could bring the first off-the-shelf CAR-T drug to market.

The promising, albeit early, data from the study released Wednesday found that 100% of evaluable patients with either non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia who had relapsed following CAR-T treatments, and who had received an average of five lines of prior treatment, responded to Precision’s lead therapy PBCAR0191.

The PI3K inhibitors were once viewed as a blockbuster opportunity in blood cancer. But patient deaths in clinical trials for earlier-line use of Gilead Sciences’ first-to-market Zydelig dashed that hope. Now, in what could be viewed as a redemption of the drug class, Bayer’s Aliqopa has come up with a success safely.

ASH is back and Loxo is primed and ready to present new data that they think will be quite exciting.

The Lilly-owned company is announcing results from a Phase I/II trial on its LOXO-305 program, and Saturday afternoon they detailed data in patients with mantle cell lymphoma (MCL) and other non-Hodgkin lymphomas. It’s the first of two expected presentations on the drug, as researchers are planning on releasing results from another patient population within the trial Monday.

The next three months will be among the most consequential in the Food and Drug Administration's modern history.

This fall, at least two of the leading coronavirus vaccine makers could seek emergency approvals, setting up what will be a series of momentous decisions for the regulator. The FDA will face immense pressure to clear a vaccine, but will be forced to make a call with significantly less information than usual to go on, due to the extraordinary speed at which developers have proceeded.

Should the agency authorize an experimental vaccine for emergency use, or grant a full approval, tens of millions of people will likely receive a shot, even under a controlled roll-out to high-risk groups.

There is a noteworthy update this afternoon in the long-running effort to turn cells from healthy donors into effective cancer treatments — data suggesting an experimental therapy from Allogene Therapeutics may help very sick patients with non-Hodgkin lymphoma.

Roche has rolled out new data showing mosunetuzumab can trigger complete responses in a tough group—lymphoma patients failed by CAR-Ts and other drugs. The phase 1/2b linked the bispecific antibody to long-lasting responses in a significant minority of hard-to-treat non-Hodgkin lymphoma patients.

Germany’s Morphosys has announced results from its combination therapy of an experimental antibody and Celgene’s Revlimid in a common form of non-Hodgkin lymphoma, saying that the phase 2 trial data is compelling enough to file with regulators later this year.