Tepylute (SH 105) gains FDA approval for breast and ovarian cancers
Shorla Oncology received an FDA approval for SH 105 (Tepylute) for patients with breast and ovarian cancers
The New Drug Application (NDA) for SH 105 highlighted its prediluted injectable format, simplifying administration and promoting accurate dosage. Originally established in the 1950s, SH-105 was utilized as a freeze-dried powder, thiotepa (Tepadina), and experienced supply chain shortages. With the liquid formula, SH -105 eliminates the need for powder to be reconstituted. Overall, the liquid formula has improved efficacy and reduces risks associated with the complexity of preparation.
Prior to SH 105’s approval, Shorla Oncology held a pre-investigational new drug application (IND) meeting with the FDA in 2019. The meeting concluded successfully with developers agreeing SH105 has various benefits for patients with breast and ovarian cancers.
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