Articles related to DEVICE/DRUG APPROVALS

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?

Iyuzeh (latanoprost ophthalmic solution), which will be offered to eyecare professionals in the US in the second half of 2023, is made without any of the preservatives often included in topical ocular treatments, such as benzalkonium chloride (BAK). Iyuzeh has consistently lowered IOP and been shown to be tolerable in numerous trials in the US and Europe. In randomized, controlled clinical studies, Iyuzeh reduced IOP by 3–8 mmHg against 4–8 mmHg by Xalatan (latanoprost ophthalmic solution) at 0.005%, which is preserved with BAK, in patients with open-angle glaucoma or ocular hypertension and mean baseline IOP of 19–24 mmHg.

Chronic pain affects more than 20% of the US population. More than a dozen new medical therapies are being developed to improve quality of life and reduce the risk of addition. This report summarizes the status of 17 new pain management medications in the pipeline: 16 in phase 3 trials and one newly approved.

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.

Not surprisingly, given the rate at which new FDA approvals are granted, the majority of clinicians prescribed a newly FDA-approved drug in the previous year, with 20% prescribing at least ten new drugs, according to OBRs Oncology Drug Report 2022. The latter metric demonstrates how quickly the world of cancer care is evolving, which has a number of important implications for oncology practice.

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).