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Seagen's (SGEN) Tukysa Gets Accelerated FDA Nod for New Indication

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Seagen Inc. (SGEN - Free Report) announced that the FDA has granted accelerated approval to its cancer drug, Tukysa (tucatinib), in combination with Roche's (RHHBY - Free Report) Herceptin (trastuzumab), to address a new indication.

The FDA has now approved Tukysa in combination with Herceptin for treating adult patients with RASwild-type, HER2-positive unresectable or metastatic colorectal cancer whose disease progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

This marks the first FDA nod for treatment in HER2-positive metastatic colorectal cancer. The continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.

Shares of Seagen have jumped 3.5% in the past year against the industry’s decline of 7.1%.

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In September 2022, the FDA accepted for priority review SGEN’s supplemental new drug application (sNDA) seeking approval for Tukysa plus Herceptin for treating adult patients with HER2-positive colorectal cancer, who have received at least one prior treatment regimen for unresectable or metastatic disease.

The sNDA was based on data from the pivotal phase II MOUNTAINEER study. Data from the same showed that the combo of Tukysa plus trastuzumab demonstrated a confirmed objective response rate of 38% 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 previously 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.

In April 2020, the FDA approved Tukysa in combination with Roche's Xeloda (capecitabine) and Herceptin 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 nine months of 2022, Tukysa generated sales worth $267 million, reflecting an increase of 11% on a year-over-year basis. Label expansion of the drug is likely to boost sales further in the days ahead.

Zacks Rank & Stocks to Consider

Seagen currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) and Arcus Biosciences, Inc. (RCUS - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present.You can see the complete list of today’s Zacks #1 Rank stocks here.

Loss per share estimates for Syndax Pharmaceuticals have narrowed 6.5% for 2023 in the past 60 days.

Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.

Loss per share estimates for Arcus Biosciences have narrowed 5.9% for 2023 in the past 60 days.

Earnings of Arcus Biosciences surpassed estimates in two of the trailing four quarters, met the same once and missed on the other occasion. RCUS witnessed an earnings surprise of 56.74% on average.

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