Seagen's (SGEN) Tukysa Gets FDA Priority Review for New Indication
Seagen Inc. SGEN recently announced that the FDA has accepted for priority review its supplemental new drug application (sNDA) for its marketed drug, Tukysa (tucatinib), in combination with Roche's RHHBY Herceptin (trastuzumab), to address a new indication.
The sNDA is seeking approval of Tukysa in combination with Herceptin for treating adult patients with HER2-positive colorectal cancer, who have received at least one prior treatment regimen for unresectable or metastatic disease.
Per the company, currently, there is no approved treatment for metastatic colorectal cancer that targets HER2 specifically.
With the FDA granting priority review to the sNDA, a decision from the regulatory body is expected on Jan 19, 2023.
The sNDA was based on data from the pivotal phase II MOUNTAINEER study.
Shares of Seagen have decreased 9.8% this year compared with the industry’s decline of 23.5%.
In May 2022, SGEN announced positive top-line data from the pivotal phase II MOUNTAINEER study, which investigated Tukysa plus Herceptin in patients with previously-treated HER2-positive metastatic colorectal cancer.
The study showed that the combo of Tukysa plus Herceptin demonstrated a confirmed objective response rate of 38.1% per blinded independent central review (“BICR”). The median duration of response was 12.4 months per BICR.
The combination of Tukysa and Herceptin was generally safe and well-tolerated.
The FDA granted Breakthrough Therapy designation to Tukysa in combination with Herceptin in July 2022, for treating adult patients with unresectable or metastatic HER2-positive colorectal cancer, who have previously received fluoropyrimidine, oxaliplatin and irinotecan-containing chemotherapy.
In April 2020, the FDA approved Tukysa in combination with Roche's Herceptin and Xeloda (capecitabine) to treat adult patients with HER2-positive locally advanced or metastatic breast cancer and those who have received at least two prior anti-HER2 treatment regimens.
The European Commission granted marketing authorization to the same Tukysa combo for the same indication in February 2021.
The global phase III MOUNTAINEER-03 study is evaluating Tukysa plus Herceptin and standard chemotherapy versus chemotherapy given with or without cetuximab or bevacizumab for treating first-line HER2-positive metastatic colorectal cancer.
In the first six months of 2022, Tukysa generated sales worth $179.5 million, reflecting an increase of 17% on a year-over-year basis. A potential label expansion of the drug is likely to boost sales further in the days ahead.
September 21, 2022
