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Seagen's (SGEN) Cancer Portfolio Strong, Stiff Rivalry a Worry

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Seagen Inc. SGEN is making good progress with its portfolio of marketed drugs — Adcetris, Padcev, Tukysa and the newly approved Tivdak — targeting different types of cancer indications.

Seagen’s lead drug, Adcetris, is approved for treating Hodgkin lymphoma, certain T-cell lymphomas, as well as other cancers in the United States, Europe and several countries. Adcetris is approved by the FDA for six indications.

Seagen has an agreement with Japan’s Takeda Pharmaceutical Company TAK for further development and commercialization of Adcetris. The company records royalty revenues on the sales of Adcetris from Takeda in the ex-U.S. markets.

Seagen’s second drug, Padcev, is approved for the treatment of patients with advanced/metastatic urothelial cancer, having been previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.

In July 2021, the FDA approved two supplemental biologics license applications (sBLA) that sought a label expansion for Padcev. The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only drug approved by the FDA to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin.

In April 2020, the FDA approved Seagen’s third drug, Tukysa, in combination with Roche's RHHBY Herceptin and Xeloda for treating adult patients with locally advanced/metastatic HER2-positive breast cancer, including those with brain metastases, having received one or more prior anti-HER2-based regimens in the metastatic setting.

Seagen is also evaluating Tukysa in combination with Roche’s Herceptin and as a single agent for treating patients with HER2-positive metastatic colorectal cancer (mCRC) who were previously treated with first- and second-line standard-of-care therapies.

In September 2021, the FDA granted accelerated approval to Tivdak (tisotumab vedotin-tftv) for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. The drug is being developed in collaboration with Denmark’s Genmab A/S GMAB.

The approval for Tivdak has now added a fourth drug to Seagen’s portfolio, which should drive growth for the company in 2021 and beyond. However, heavy reliance on Adcetris, which constitutes the majority of the company's top line, is concerning. Stiff competition from other companies in the target market also remains a headwind.

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