NEW YORK – The National Health Service England on Friday said it will fast track the availability of Takeda's Exkivity (mobocertinib) for metastatic non-small cell lung cancer patients who have EGFR exon 20 insertion mutations in their tumors and have already received chemotherapy.
NHS England said that the drug will become available to patients in the country "within weeks" after it brokered an agreement between the National Institute for Health and Care Excellence (NICE) and Takeda.
The deal follows Exkivity's expedited approval by the UK's Medicines and Healthcare Products Regulatory Agency in January. MHRA reviewed data from a Phase I/II trial, in which Exkivity shrank tumors in 28 percent of 114 patients. The median duration of response was 17.5 months, median progression-fee survival was 7.3 months, and overall survival was 24 months.
The MHRA accessed this data through the US Food and Drug Administration-led Project Orbis, an international partnership between health regulators in the UK, US, Australia, and other countries aimed at speeding access to innovative drugs around the world. According to NHS England, Exkivity is the fourth precision oncology drug reviewed through Project Orbis — after AstraZeneca's Tagrisso (osimertinib), Genentech's Tecentriq (atezolizumab), and Amgen's Lumykras (sotorasib) — that the government has been able to fast track access to.
The FDA approved Exkivity for the same indication last September. The NHS estimated that Takeda launched Exkivity in the US at a wholesale acquisition cost of $25,000 for a one-month supply of the oral pill.
In the early-access deal in England, Takeda has agreed to make Exkivity available to patients on a budget-neutral basis while NICE completes its cost-effectiveness appraisal.
"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," Helen Knight, program director at NICE's Center for Health Technology Evaluation, said in a statement. "Collaboration is critical to our role in bringing innovative treatments to patients as rapidly as possible."
Because of this arrangement, NSCLC patients in England will be the first patients in Europe to receive the drug, according to NHS England. Patients with advanced NSCLC with EGFR exon 20 insertion mutations tend to be young, nonsmokers, and have tumors that can't be surgically resected. Approximately 100 advanced NSCLC patients a year will be eligible for Exkivity.