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03-12-2018 | FDA | Drug approval | News

approvalsWatch

Positive FDA decisions for lorlatinib, talazoparib, pembrolizumab

medwireNews: The US FDA has announced approvals for the anaplastic lymphoma kinase (ALK) inhibitor lorlatinib and the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib, while the indications of the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab have been expanded.

Lorlatinib can now be administered to patients with metastatic ALK translocation-positive non-small-cell lung cancer (NSCLC) who have either progressed after treatment with crizotinib and at least one other ALK inhibitor or after treatment with alectinib or ceritinib as the first ALK inhibitor.

The decision is based on trial results showing an overall response rate (ORR) of 48% among 215 patients who had previously received one or more ALK inhibitor.

It is recommended that lorlatinib be given at a dose of 100 mg/day orally.

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Following the findings of the phase III EMBRACA trial, the FDA has given the nod to talazoparib for patients with locally advanced or metastatic HER2-negative breast cancer and deleterious or suspected deleterious germline BRCA mutations.

The regulatory body has also approved an accompanying diagnostic test – the BRACAnalysis CDx test (Myriad Genetics, Salt Lake City, Utah, USA) – to be used to identify patients eligible for talazoparib therapy.

The PARP inhibitor should be administered orally at a dose of 1 mg/day, with or without food.

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Pembrolizumab has been approved for use alongside chemotherapy – specifically, carboplatin plus paclitaxel or nab-paclitaxel – for patients with previously untreated metastatic squamous NSCLC and as monotherapy for advanced hepatocellular carcinoma (HCC) patients who have previously received sorafenib.

These decisions follow on from the results of the KEYNOTE-407 and KEYNOTE-224 trials, respectively.

The KEYNOTE-407 study comprising 559 patients with metastatic nonsquamous NSCLC regardless of PD-L1 tumor expression showed a significant improvement in overall survival, progression-free survival, and ORR among participants who received pembrolizumab rather than placebo alongside first-line chemotherapy.

And in the single-arm KEYNOTE-224 trial, 17% of the 104 participants with advanced HCC had a response to treatment with the anti-PD-1 agent.

The recommended dose for both indications is 200 mg given every 3 weeks.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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