NHS grants fast-track access to Takeda's lung cancer drug Exkivity

Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Exkivity (mobocertinib) as a monotherapy for non-small-cell lung cancer (NSCLC) patients whose tumours have EGFR exon20 insertion mutations, after first-line chemotherapy.

At the same time, NHS England, cost-effectiveness watchdog NICE and Takeda have agreed an early access deal for the drug that includes a discount on its monthly cost of around £19,000 ($25,000).

Exkivity will be available to eligible patients in England "on a budget-neutral basis to the NHS while NICE completes its ongoing appraisal," according to Health and Social Care Secretary Sajid Javid.

It is thought that around 100 people per year in England will be eligible for treatment with the drug, the first oral therapy specifically designed for people with this rare and aggressive type of lung cancer.

Another drug targeting the EGFR exon20 mutation – Johnson & Johnson's Rybrevant (amivantamab) – is under regulatory review by the MHRA and NICE but is administered by intravenous infusion.

"Trials show that some patients who have taken mobocertinib have lived for two years after being treated with the breakthrough drug – significantly longer than expected for patients with this type of lung cancer," said NHS England.

Exon 20 insertions are seen in about 10% of patients who present with EGFR mutations, and 2% of NSCLC patients overall.

NHS national medical director Prof Stephen Powis said that patients in England will be the first in Europe to get access to Exkivity – at a price that is affordable for the taxpayer – "thanks to another deal struck by the NHS."

Earlier examples include deals for Amgen's first-in-class KRAS inhibitor Lumykras (sotorasib) for KRAS-mutated NSCLC, Novartis' cholesterol lowering Leqvio (inclisiran) that can be dosed once every six months, and AstraZeneca's Tagrisso (osimertinib) for NSCLC with EGFR exon 19 or exon 21 mutations.

The Exkivity agreement comes under Project Orbis, a global project run by the FDA that the MHRA is supporting, which aims to allow patients faster access to innovative cancer treatments.

Exkivity was approved by the FDA last year and is also under regulatory review in the EU. Takeda has previously said that Exkivity could make up to $600 million in peak sales, assuming it is approved down the line for first-line use.