Takeda pulls Exkivity lung cancer app in EU as Velcade generics cost oncology franchise dearly

Takeda’s oncology department just got hit with a double whammy.

Fresh U.S. generic competition took a big bit out of what used to be its best-selling product, Velcade. And regulators gave a cold shoulder to its new lung cancer therapy Exkivity.

Takeda decided to pull an application for FDA-approved Exkivity in the EU for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations, the company said Thursday.

The decision comes after reviewers at the European Medicines Agency said they would need more clinical data to confirm the Exkivity's benefits for second-line patients, Takeda CEO Christophe Weber said during an investor call Thursday.

Exkivity sits among a first wave of expected new drug launches that Takeda is building before its top-selling drug, the inflammatory bowel disease therapy Entyvio, loses patent protection in the U.S.

Before the EMA withdrawal, Exkivity had won approvals in several countries, including the U.S. and the U.K. Since its U.S. launch in September 2021, Exkivity, an oral drug, has reached 50% share of the exon 20 market, Weber said. The other half belongs to Johnson & Johnson’s antibody infusion Rybrevant.

Sales of the Takeda med in the three months ending in June reached 700 million Japanese yen ($5.2 million). That’s still a long ways to go from Takeda’s peak sales projection of $300 million to $600 million.

A big part of Exkivity’s market opportunity lies in newly diagnosed NSCLC. Regulatory filings, including in Europe, for first-line treatment are planned for 2024, pending readout from the phase 3 Exclaim-2 study, Weber said.

The second blow to Takeda’s oncology business for the second quarter came from widely used blood cancer drug Velcade.

Thanks to multiple U.S. generic entries since May, Velcade’s global sales dropped by more than half at constant currencies to 16.5 billion yen ($120 million). That was in contrast to the 3% revenue growth Velcade pulled off in the fiscal year that ended in March.

Speaking to the popularity of the proteasome inhibitor, seven generics to Velcade have already hit the U.S. market, and Takeda expects to see another 10 “in the coming weeks,” CFO Costa Saroukos told investors during the call.

Velcade's follow-up drug, Ninalro, also suffered during the quarter, with sales dropping 13% to 23.7 billion yen as competition heats up.

Those disappointments dragged down Takeda’s entire oncology portfolio. Its 117.5-billion-yen ($870 million) sales during the quarter marked a jarring 10% decline at unchanged exchange rates. Thanks to a weak yen, the decrease looks milder at 3.2%.

In fact, among Takeda’s five therapeutic divisions, oncology was the only one that suffered a decline. In gastroenterology, Entyvio drove sales with 19% year-over-year growth to 168.3 billion yen ($1.25 billion). Takhzyro’s 19% increase boosted Takeda’s rare disease portfolio, just as Vyvanse lifted the neuroscience section. And plasma-derived therapies also chalked up double-digit growth thanks to immunoglobulin products.

For the rest of the fiscal year, Takeda expects a key phase 3 readout to potentially move Livtencity to first-line treatment of post-transplant cytomegalovirus infection. The Japanese pharma also expects a European decision on dengue vaccine TAK-003 before the end of next March, slightly earlier than its previous update.