Current Edition

Takeda’s Exkivity receives MHRA conditional marketing authorisation

Approval of Exkivity could mean NHS access to ground-breaking treatment for patients with rare lung cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Exkivity (mobocertinib), as a monotherapy treatment for adult patients with epidermal growth factor receptor (EGFR) locally advanced or metastatic non-small cell lung cancer. The patients involved will have received prior platinum-based chemotherapy.

This approval marks a significant milestone, as there have previously been no targeted treatments NHS reimbursed for this specific type of lung cancer. EGFR Exon20ins+ NSCLC (non-small cell lung cancer) primarily affects younger people and non-smokers and carries a worse prognosis than other EGFR mutations.

Due to the aggressive nature of the disease, there have previously been no treatments that specifically target the EGFR Exon20ins mutation.

Angela Terry, Chair of EGFR Positive UK reflected on the MHRA decision: “The impact of a cancer diagnosis is devastating enough, but to then understand that there are no treatments routinely available for your specific type of disease can often make patients feel frustrated and alone. So, it is fantastic news that EGFR Exon20 insertion NSCLC patients will now have the opportunity to benefit from an oral, targeted treatment that offers the hope of potentially improved outcomes.”

We also hope that having targeted treatments available will mean that patients are tested more effectively at diagnosis for this specific mutation – something that has historically been quite variable across the country,” she added.

Professor Sanjay Popat, consultant medical oncologist, at The Royal Marsden NHS Foundation Trust explained: “The accelerated approval of mobocertinib is testament to the difference this treatment could make to patients that are in critical need of a targeted treatment option. The clinically meaningful benefits and generally manageable side effect profile that mobocertinib can offer to patients marks a step-change in the treatment of this disease and provides hope to patients and their families.

“The oral administration also adds further value to this treatment option, not only from a patient experience perspective but also in reducing the number of hospital visits for patients whilst we still navigate the global pandemic.”

The next step is ensuring that eligible patients across the UK have access to mobocertinib. Takeda is currently working with NHS England to make the treatment available via a National Orbis Drug Access Arrangement.