FDA granted Fast Track designation to Debiopharm for the use of its PKMYT1 inhibitor, lunresertib (Debio2513), and its WEE1 inhibitor, zedoresertib (Debio 0123) for the treatment of adult patients with CCNE1 amplified, or a deleterious mutation in either FBXW7 or PPP2R1A, platinum-resistant/refractory ovarian cancer.
FDA announced that it has achieved its first-year goals in implementing its roadmap to reduce animal testing in preclinical studies.
