Articles related to FDA

Approved? Not-approved? What is “tentative approval?” Clinical trial data on this novel “once nightly” sodium oxibate showed the drug to be acceptable for narcolepsy. But legal issues are holding up the FDA approval process.

The decision to remove Lumoxiti from the US market was attributable to its extremely poor clinical uptake because there were other treatment choices available, according to AstraZeneca’s letter to healthcare professionals. Its limited uptake may also have been caused by the complicated administration, the requirement for toxicity prophylaxis, and the need for safety monitoring. The elimination has nothing to do with the drug’s efficacy or safety.

Spectrum Pharmaceuticals would need to study the drug further, including generating data from a randomized controlled trial, according to the release. Spectrum responded by stating that it would “de-prioritize poziotinib program activities, effective immediately.” The decision comes after the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the drug’s demonstrated clinical benefit did not outweigh its risks.

Data from Study 2102-HEM-101, an open-label, single-arm, multicenter phase 1/2 trial, were used to support the approval. The Abbott RealTime IDH1 Assay was used to identify 147 adults with relapsed or refractory AML who had an IHD1 mutation. Olutasidenib treatment resulted in a 35% complete remission (CR) or complete remission with partial hematologic recovery in patients (CRh).

In comparison to 72% of patients who received placebo, 45% of those who received teplizumab-mzwv (Tzield, Provention Bio) over the course of a median follow-up of 51 months were found to have stage 3 type 1 diabetes. Teplizumab-mzwv appeared to delay the onset of type 1 diabetes by about two years, as the median time from randomization to diagnosis of stage 3 diabetes was 50 months in the teplizumab-mzwv group and 25 months in the placebo group.

This approval was based on findings from the open-label, randomized, multicenter POSEIDON trial, which compared data from two of the study’s three treatment arms. When compared to patients in the other treatment arm, patients in this group had a significantly improved OS, with a median OS of 14 months as opposed to 11.7 months.