As the second antibody-drug conjugate launched by Daiichi Sankyo and AstraZeneca, Datroway has a tough act to follow, coming on the heels of the companies’ emerging ADC cancer powerhouse Enhertu.
But so far, so good for the TROP2-directed treatment, which was endorsed in Japan in December and in the U.S. in January. Through the end of March—which concluded Daiichi’s fiscal year—Datroway generated (PDF) sales of 1.4 billion Japanese yen ($10 million).
It was an indication of a “smooth market launch,” Daiichi CEO Hiroyuki Okuzawa said on a conference call late last week.
Datroway has been approved for unresectable or metastatic, hormone receptor positive, HER2-negative breast cancer in patients who have tried prior endocrine-based therapy and chemotherapy.
A much larger market opportunity awaits for Datroway, however, as a potential treatment for non-small cell lung cancer (NSCLC). Its entrance into the indication could come in the second half of this year as the companies are awaiting a July 12 FDA decision date for Datroway to treat patients with EGFR-mutated NSCLC who have received prior systemic therapies.
The submission came after the companies pulled their original FDA filing for Datroway in second-line nonsquamous NSCLC after the phase 3 Tropion-Lung01 study showed mixed results. The pair has refiled in pretreated EGFR-mutated NSCLC using a pooled subgroup analysis from Tropion-Lung01 and the phase 2 Tropion-Lung05 trial.
For now, Daiichi is projecting sales of Datroway in the new fiscal year to reach 4.7 billion Japanese yen ($33 million). As the company works to hit that goal, a recent approval in Europe should help.
In 2020, AZ made a big bet on Datroway, paying Daiichi $1 billion upfront and committing up to $5 billion tied to potential regulatory and sales milestones. AZ has projected peak sales of Datroway at $5 billion.
Datroway is competing with Gilead Sciences' TROP2-targeted ADC Trodelvy, which has been on the market since 2020, has been approved in three indications and generated sales of $1.3 billion last year. Earlier this month, Gilead reported a key trial win as a combination of Trodelvy and Merck’s Keytruda bested Keytruda alone in patients with previously untreated metastatic triple-negative breast cancer.
The bright expectations for Datroway have come following the success of Enhertu, which logged sales of $3.7 billion in Daiichi's 2024 fiscal year. The company is projecting sales of the treatment to reach 662 billion Japanese yen in this fiscal year ($4.6 billion).
As for the company overall, Daiichi’s revenue came in at 1.886 trillion Japanese yen ($13.2 billion) for the year, which was an 18% increase from FY 2023.
The Tokyo-based company expects to see a slowdown in growth in this fiscal year, estimating its sales will reach 2 trillion Japanese yen ($14 billion), or roughly a 6% increase. The projection does not include any potential tariff implications, Daiichi said.