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 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.
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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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