EMA starts review of Novartis’ latecomer PD-1 drug tislelizumab

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July.

Novartis said the EMA is assessing the cancer immunotherapy as a first-line treatment alongside chemotherapy for squamous or non-squamous NSCLC and as a second-line monotherapy for this type of cancer, as well as for oesophageal squamous cell carcinoma patients previously treated with chemo.

In the US, the FDA is only reviewing the oesophageal cancer indication, while tislelizumab is already approved in China for NSCLC, classical Hodgkin lymphoma and hepatocellular carcinoma (HCC).

The Swiss pharma giant licensed ex-China rights to tislelizumab from BeiGene in February 2021 for $650 million upfront and up to $1.55 billion in milestones, shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

There are already several PD-1/PD-L1 inhibitors on the market, and if approved tislelizumab will come up against Merck & Co’s dominant Keytruda (pembrolizumab) and others in the NSCLC indications, as well as Keytruda and Bristol-Myers Squibb’s Opdivo in oesophageal cancer.

Novartis will be hoping for a better regulatory outcome for its China-sourced PD-1 antibody than Eli Lilly, whose Innovent-licensed Tyvyt (sintilimab) was rejected by an FDA panel as a first-line treatment for NSCLC on the grounds that its application was based only on Chinese data.

In its favour is that the phase 3 studies submitted in support of both the oesophageal cancer  and NSCLC indications are based on patients from Asia, Europe and the Americas.

Novartis has a wide-ranging phase 3 trial programme for tislelizumab on the go as it tries to catch up with its rivals, including as a first-line therapy for oesophageal, gastric, bladder, small cell lung and liver cancers as well as nasopharyngeal carcinoma.

FDA clears Vijoice for rare overgrowths

Meanwhile, Novartis has also claimed an FDA approval for Vijoice, a new product based on its PI3K inhibitor alpelisib, for a clutch of overgrowth disorders under PI3KCA-related overgrowth spectrum (PROS) umbrella term.

The rare disorders are characterised by atypical growth in tissues and anomalies in blood vessels, the lymphatic system and other tissues, and include conditions like Klippel–Trenaunay syndrome (KTS), CLOVES syndrome and benign lichenoid keratosis.

Taken together, PROS affect around 14 people per million, and Vijoice is the first drug therapy to be approved to treat the disorders. The green light is based on real-world data from EPIK-P1 study, which showed patients treated with Novartis’ drug saw reduction in the size of PROS lesions and improvement of PROS-related symptoms.

Alpelisib has been approved since 2019 under the Piqray brand as a targeted treatment for  PI3KCA-mutated breast cancer in combination with fulvestrant.

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