Seagen and Genmab Obtain Rapid FDA Approval for Cervical Cancer Drug

Dive brief:

  • The Food and Drug Administration has approved the drug Tivdak from Seagen and Genmab for patients with cervical cancer whose tumors have come back or spread after chemotherapy. Tivdak is the first of its kind to target a protein called tissue factor which is frequently expressed on cancer cells.
  • Tivdak’s approval is the fourth for Seagen and Genmab, the latter having launched other products in partnership with Johnson & Johnson, Novartis and Roche. Tivdak, a type of medicine called an ‘antibody-drug conjugate’, is made up of an antibody targeting proteins belonging to Genmab and Seagen technology that binds a tumor-killing chemical.
  • Tivdak was granted fast-track clearance based on the results of a study showing it reduced tumors in a group of patients with few treatment options. Seagen and Genmab will need to confirm its safety and effectiveness in a trial that will test whether it can help patients live longer than those on chemotherapy. The companies have set the drug’s list price at about $ 34,000 per month.

Dive overview:

Tivdak offers doctors and patients another option for a disease that has not seen much progress in treatment beyond traditional chemotherapy.

Avastin from Roche and Keytruda from Merck & Co. are more recent entries, but have shown only modest effectiveness. Avastin added to chemotherapy improved survival by about four months compared to chemotherapy alone, while Keytruda reduced or eliminated tumors in about 14% of patients whose cancer expressed a protein marker associated with responses to treatment.

Tivdak, by comparison, has shown signs that it works without chemotherapy, as does Avastin, and in a larger patient population than Keytruda. In a small trial called InnovaTV 204 which supported fast track approval, treatment with Tivdak reduced or eliminated tumors in 24% of patients whose cancer had progressed after Avastin plus chemo and to other previous treatment. Seven percent of study participants experienced complete responses to treatment.

Earlier this year, Seagen and Genmab began enrolling patients in a larger trial called InnovaTV 301 to confirm that Tivdak can help patients live longer than chemotherapy. However, this trial may not yield results for three years.

Meanwhile, the two partners tested the treatment in patients with early-stage disease.

At the meeting of the European Society for Medical Oncology, they released data from another trial called InnovaTV 205, which tested Tivdak in a number of combinations and settings. In patients who have never received systemic therapy before, Tivdak plus chemo reduced or eliminated tumors in 55% of patients, helping them to live a median of more than nine months without their disease progressing. With Keytruda in patients after two or three previous treatments, Tivdak planted or eliminated tumors in 38% of patients and led to a median progression-free survival of almost six months.

In the early stages of the disease, however, Keytruda showed more impressive efficacy, reducing the risk of death by more than 30% in the KEYNOTE-826 trial, which combined it with chemotherapy and Avastin. Stephen Willey, analyst at Stifel, wrote in a September 19 note to customers that the data suggests that Keytruda will need to be part of a first-line combination therapy.

Seagen launched its first product, an antibody-drug conjugate called Adcetris, in 2011. Since late 2019, the Seattle-based biotech company has now gained approval for three more, and last year has made a profit for the first time thanks to license revenue. The agreements. Tivdak could further increase Seagen’s bottom line.

About Margie Peters

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