NHS fast tracks new ‘gamechanging’ drug for lung cancer

A targeted new drug for a rare and aggressive form of lung cancer will be fast-tracked to eligible patients within weeks, thanks to a deal brokered by NHS England.

Patients in England will be the first in Europe to access Mobocertinib – the only precision drug available to patients with a mutation-driven, advanced form of lung cancer, who have already received chemotherapy.

The treatment will be available to around 100 eligible patients a year with the rare form of cancer that cannot be removed by surgery, which mainly affects younger people and non-smokers.

Mobocertinib, taken as a tablet, specifically targets the mutation to slow the growth of cancer cells, with manageable side effects.

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.

The access comes alongside approval from the MHRA and an early access agreement struck by NHS England, NICE and the manufacturer, Takeda.

The NHS Long Term Plan is committed to providing the latest cutting-edge treatments and therapies for patients as well as providing faster access to promising new cancer treatments on the NHS.

Professor Stephen Powis, NHS national medical director said: “It is fantastic news that patients in England with this extremely rare and aggressive form of lung cancer will be the first in Europe to receive this gamechanging treatment thanks to another deal struck by the NHS.

“From life-changing drugs for blood cancer to new treatments for lung cancer, this is the latest in a long list of deals we have struck to provide the latest cutting-edge cancer treatments for patients – at a price that is affordable for the taxpayer.

“The NHS has continued to prioritise cancer care throughout the pandemic and I urge anyone with concerns, to come forward and get checked”.

Newly approved by the MHRA, the NHS will begin to offer the new drug to eligible lung cancer patients within weeks, following the latest early access agreement reached by NHS England.

Mobocertinib will be accessible to eligible lung cancer patients in England on a budget-neutral basis to the NHS while NICE completes its ongoing appraisal.

Health and Social Care Secretary Sajid Javid said: “NHS patients are the first in Europe to benefit from this cutting-edge new treatment for lung cancer – mobocertinib is a breakthrough drug which will be a lifeline for those with this rare form of the illness.

“Our early access agreement through Project Orbis, an international partnership, has allowed us to make this drug available on an accelerated timescale – a fantastic example of post-Brexit global collaboration ensuring UK patients receive the best possible care and treatment for cancer”.

Mobocertinib will be accessible to eligible lung cancer patients in England on a budget-neutral basis to the NHS while NICE completes its ongoing appraisal.

Dame June Raine, MHRA Chief Executive said: “Through the MHRA’s membership of Project Orbis, an innovative programme coordinated by the US Food and Drug Administration (FDA) with other regulators across the world, we are working to ensure that patients receive earlier access to promising cancer treatments.

“Following our rigorous review, mobocertinib, an innovative treatment, can be prescribed to patients suffering with certain types of lung cancer, enabling the NHS to extend patient access to this life-saving treatment”.

Helen Knight, programme director in the Centre for Health Technology Evaluation at NICE, said: “I’m delighted we have been able to work with Takeda, the MHRA and NHS England to reach an agreement to make mobocertinib available for people with this type of lung cancer while we complete our evaluation.

“Collaboration is critical to our role in bringing innovative treatments to patients as rapidly as possible”.

This is the fourth drug which has been made available by the NHS in England through an early national access agreement following a Project Orbis licence, and similar NHS agreements for Osimertinib, Atezolizumab, and cutting-edge therapy Sotorasib which targets the so-called “death star” mutation.

The deal has been agreed with drug manufacturer Takeda under Project Orbis, which is an international partnership between medicines regulators in the UK, US, Australia and others, set up to speed up the approval process for promising cancer treatments.

Emma Roffe, Oncology Country Head – UK and Ireland, Takeda UK Ltd, said: “Takeda is delighted that access to mobocertinib will be expedited for eligible patients with EGFR Exon20 NSCLC who are in dire need of targeted treatment options. The close partnership between Takeda, the MHRA and NHS England to recognise the value of this innovative treatment, is testament to our shared commitment to provide the best care and deliver improved outcomes for patients”.