In their running battle to treat a rare form of non-small cell lung cancer, Johnson & Johnson got the jump on Takeda in the United States last year. But now Takeda has one-upped J&J in the U.K.

England’s Medicines and Healthcare Products Regulatory Agency has conditionally approved Takeda’s Exkivity in a subset of patients with NSCLC. The approval is for those whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations after chemotherapy and disease progression.

Combined with a deal with England’s drug price watchdog NICE to provide Exkivity at a discount, the oral treatment could be available within weeks. The reduced monthly price tag is £19,000 ($25,000) as NICE continues its ongoing appraisal.

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 allows for patient access as the treatment is being evaluated.  

"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.”