FDA approves Merck & Co, Gilead and Alkermes therapies

The US Food and Drug Administration has granted accelerated approval for Merck & Co’s immunotherapy Keytruda for advanced non-small cell lung cancer in patients whose disease has progressed after other treatments and with tumours that express the protein PD-L1.

The agency has backed Keytruda (pembrolizumab) for use with a companion diagnostic made by Dako – PD-L1 IHC 22C3 pharmDx  – which is the first test to determine which NSCLC patients are eligible for treatment. The approval is based on data showing that Keytruda shrank tumours in 41% of pre-treated patients with advanced disease and PD-L1 positive tumours, and that this effect lasted between 2.1 and 9.1 months.

Already approved for advanced melanoma  

Keytruda became the first US-approved PD-1 inhibitor last year when it for the green light for advanced melanoma, and is now also the first and only anti-PD-1 therapy approved for both squamous and non-squamous metastatic NSCLC.

Bristol-Myers Squibb’s rival PD-1 checkpoint inhibitor Opdivo (nivolumab) was approved for squamous NSCLC unresponsive to chemotherapy in the the USA earlier this year.

 The FDA has also approved Gilead Sciences’ Letairis in combination with Eli Lilly’s Adcirca for the treatment of pulmonary arterial hypertension.

The thumbs-up for Letairis (ambrisentan), which is sold by GlaxoSmithKline outside the USA as Volibris and Adcirca (tadalafil) is specifically for the reduction of the risks of disease progression and hospitalisation for worsening PAH, and to improve exercise ability. It was approved as monotherapy back in 2007 while Adcirca got the US green light in 2009.

The approval is based on data which showed that the combination therapy demonstrated superiority over Letairis and Adcirca when used as monotherapy.

The agency has also given the green light to Alkermes’ Aristada, a longer-acting version of blockbuster schizophrenia therapy Abilify, making the treatment available as a once-monthly and six-week injection.

Abilify (aripiprazole), developed by Otsuka Pharmaceuticals Co and sold by Bristol-Myers Squibb outside Japan, is already facing generic competition.