(Reuters) - Seattle Genetics Inc’s add-on therapy for an advanced form of breast cancer that has progressed despite prior treatment was on Friday approved months ahead of schedule by the U.S. Food and Drug Administration.
The oral therapy, Tukysa, will have a wholesale acquisition cost or list price of $18,500 for a 30-day supply of the pills, administered twice daily, Seattle Genetics said.
The list price is not necessarily what patients actually pay and “out-of-pocket” costs vary based on the duration of the treatment and individual healthcare plans.
Tukysa, chemically known as tucatinib, has been approved to be used in combination with Roche Holding AG’s Herceptin and Xeloda in patients whose cancer has worsened or spread despite at least one prior round of treatment.
Seattle Genetics said it would go ahead with the launch of Tukysa and rely on virtual and digital communication channels to promote the therapy, amid the coronavirus outbreak that has disrupted pharma companies’ operations.
“Our commercial and reimbursement teams are in place... We’ve been preparing for this launch now for months,” Chief Executive Officer Clay Siegall told Reuters ahead of the approval decision.
Bristol Myers Squibb Co last month won U.S. approval for its multiple sclerosis drug but decided to delay the launch due to the pandemic.
Siegall said the company did not expect disruptions to the supply of its therapies, including its two other approved cancer treatments, Padcev and Adcetris, due to the outbreak.
The company said with Tukysa it is looking to cater to 60% of the nearly 10,000 Americans who are diagnosed with metastatic HER2-positive breast cancer every year, including those whose cancer has spread to the brain.
Tukysa works by targeting the HER2 protein, a major trigger of uncontrolled cell growth in 20% of breast cancers. It is an area where Roche, the world’s biggest cancer drug maker, has been a pioneer with its best-seller Herceptin.
The company’s clinical study found that Tukysa when combined with Herceptin and Xeloda resulted in a 46% reduction in the risk of disease progression or death.
SVB Leerink analyst Andrew Berens projected peak sales of $1.2 billion by 2030 for the therapy.
The FDA was slated to decide on Tukysa by Aug. 20, and the drug is part of the regulator’s Project Orbis initiative that provides cancer patients early access to therapies in countries facing delays in regulatory submissions.
Seattle Genetics is awaiting European approval for the combination and is testing Tukysa in other cancers such as colorectal cancer.
Reporting by Saumya Sibi Joseph and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila
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