In their running battle to treat a rare form of non-small cell lung cancer, Johnson & Johnson and Takeda have been vying for regulatory approvals in the United States and U.K.
Takeda is the latest to get a win as England’s Medicines and Healthcare Products Regulatory Agency has conditionally approved Exkivity in a subset of patients with NSCLC. The nod is for those whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations after chemotherapy and disease progression.
Combined with a budget-neutral deal with England’s drug price watchdog NICE to provide Exkivity at a discount, the oral treatment could be available within weeks.
The nod gives Exkivity an edge over J&J’s Rybrevant, an intravenous treatment awaiting an endorsement in England. In May of last year, the FDA signed off on Rybrevant. Four months later, the U.S. regulator sanctioned Exkivity.
Of those with NSCLC, only about 2% have the EGFR exon 20 type, which includes about 2,000 to 4,000 patients in the U.S. The condition typically affects younger people and non-smokers and has a poor prognosis because of the aggressive nature of the disease and the difficulty in diagnosing it, Takeda said. At diagnosis, most patients are at stage 4.
Exkivitiy and Rybrevant are the only drugs designed specifically for EGFR exon 20. Other EGFR inhibitors, such as AstraZeneca’s Tagrisso, have not performed well against the subtype.
Because of the unmet need in this type of cancer, Exkivity is registered under the FDA’s Project Orbis, which provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies.
"The clinically meaningful benefits and generally manageable side effect profile that [Exkivity] can offer to patients marks a step change in the treatment of this disease,” NHS consultant Sanjay Popat said in a statement. “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.”