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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.

In terms of regulation, the PI3K inhibitor medication class had a difficult 2022. Participants in a historic FDA advisory committee meeting in April were warned about dubious safety and efficacy. Less than three months later, the FDA issued a duvelisib (Copiktra) safety warning about mortality rates. As a result, the FDA’s Oncologic Drugs Advisory Committee (ODAC) decided against recommending duvelisib’s approval for the treatment of chronic lymphocytic leukemia/small cell lymphoma (CLL/SLL). Along the way, the FDA also voluntarily withdrew or revoked a number of PI3K inhibitors’ approved indications. Does the medication class have a promising future in the treatment of hematologic malignancies in light of this negative energy?

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.

BQ.1 and BQ.1.1 together now comprise more than 50% of all COVID cases in the US. Their rapid rise – with prediction that these variants will account for more than 80% of infections by Jan. 1 – lead FDA to remove the emergency use authorization for bebtelovimab, and recommend bivalent boosters and the use of ritonavir-nirmatrelvir, remdesivir, and molnupiravir for treatment of infection.

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.