PI3K inhibitors warned by FDA of elevated threat of demise after closing trial outcomes – Endpoints Information

The FDA sent out a new warning on Thursday about Secura Bio’s obstructive PI3K inhibitor Copiktra (duvelisib), which may increase the risk of death and serious side effects for patients as a treatment. third for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia. lymphoma (SLL).

Copiktra won approval for both indications in 2018, but FDA now say that after an average of 63 months of follow-up in Phase III leading to approval, the ultimate survival results suggest a possible increased risk of death for Copiktra users, with a risk ratio of 1.09 (95% confidence interval) [CI] 0.79, 1.51). Additionally, 80/160 of the trial participants and in Copiktra eventually died, compared with 70/159 among those in Novartis’ ofatumumab, the FDA said.

“The rates of serious adverse events, dosage changes, and deaths from these side effects were also higher in patients receiving Copiktra,” the FDA added, asking doctors to discuss the new data. this with their patients and decide on the best course of action to take. .

This is just the latest warning for a class of drugs that have received closer scrutiny this year, with an FDA vote in April that all approvals for PI3K inhibitors should be backed by random data. PI3K inhibitors have recently gained traction in hematologic malignancies following concerns about new toxicity, inadequate dose optimization, limitation of trial design of single branched and related to overall survival trends.

Mark Spring

“These safety findings are similar for other drugs in the same class of PI3 kinase inhibitors,” the FDA said in a warning in Copiktra.

Meanwhile, Secura Bio in April gave the indication for accelerated approval for Copiktra as a treatment for recurrent or refractory follicular lymphoma, after the company failed to run a mandatory validation trial on the disease. this designation.

Secura Bio’s CFO Mark Spring told News about the end point Before that, Copiktra’s quick approval was a matter of money, adding:

We felt that completing the required Phase 3 testing would take too many years and be too costly. As you can understand, as a small company, we invest our limited research funds in areas that we feel will benefit our patients the most and have a reasonable return on investment. . Secura Bio believes that our research funds are better spent developing COPIKTRA to treat patients with relapsed and refractory peripheral T-cell cancer (r/r PTCL).

Copiktra, which was purchased in September 2020 by Secura Bio from Verastem in a deal worth up to $311 million plus royalties, works by blocking key signals that cause cancer cells to proliferate, possibly help reduce or stop the growth of certain types of cancer, according to the FDA.

Leave a Comment