- The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Kymera Therapeutics' ( NASDAQ: KYMR ) KT-333 to treat Cutaneous T-cell Lymphoma (CTCL).
- CTCL is rare form of cancer which begins in a type of white blood cells called T cells (T lymphocytes). The abnormal T lymphocytes attack the skin.
- Earlier in the year, KT-333 received orphan drug designation to treat Peripheral T-cell Lymphoma, the company said in a Sept. 15 press release.
- "This second orphan drug designation reinforces the potential of KT-333 to impact the lives of a broad range of patients with hematological and solid tumors by targeting STAT3, a protein that has been considered undruggable," said Kymera Co-Founder, President and CEO Nello Mainolfi.
- Kymera noted that KT-333 is being evaluated in an ongoing phase 1 trial in adult patients with relapsed/refractory liquid and solid tumors, including aggressive lymphomas.
- The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including up to seven years of market exclusivity, if approved.
- KYMR +1.11% to $28.12 premarket Sept. 15
For further details see:
Kymera KT-333 gets FDA orphan drug status for blood cancer subtype