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Shorla Launches Liquid Formulation of Thiotepa
The US Food and Drug Administration has approved a 100-mg liquid formulation vial of thiotepa (Tepylute), according to a press release from its maker, Shorla Oncology.
Tepylute is an alkylating agent that does not require reconstitution like the freeze-dried powder form of thiotepa, which has been a standard-of-care oncology drug since the 1950s.
Shorla’s new formulation is the only “ready-to-dilute multi-dose vial” of thiotepa for treating breast and ovarian cancer, the press release says. Once opened, it’s stable for 2 weeks when properly stored, “giving providers the flexibility they need when preparing and administering this very important treatment.”
The new approval saves clinicians the time it takes to inject saline into the vial of thiotepa made by other companies to reconstitute the powder. Shorla, a US-Ireland specialty pharmaceutical company, didn’t announce the price of this convenience in its press release, but it said the formulation might also reduce dosing errors.
A 15-mg vial is also now available, in addition to the 100-mg vial, the company said.
“We are excited to bring Tepylute to the US Market. It provides consistent dosing accuracy and allows for ‘just in time’ preparation, which benefits everyone, especially patients,” Rayna Herman, chief commercial officer of Shorla, said in the press release.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
