The FDA has awarded Clovis’ Rubraca its second approval as a maintenance treatment for patients with recurrent ovarian (epithelial ovarian, fallopian tube and primary peritoneal) cancer who are in a complete or partial response to platinum-based chemotherapy. The poly(ADP-ribose) polymerase (PARP) inhibitor works by blocking the repair of damaged DNA in cancer cells leading to the death of those cells. This conversion of Rubraca to a full approval from its previous conditional approval was based upon phase 3 (ARIEL3) data which showed that it extended progression-free survival (PFS) versus placebo in all patients, regardless of their BRCA status. If you would like to read more please read the PharmaTimes article here.
After positive phase 1 and 2 results in skin cancer, Incyte’s IDO1 inhibitor epacadostat and Merck’s PD-1 inhibitor Keytruda combo were hoped to be a potential improvement on the BMS’ regimen of Opdivo and Yervoy. Unfortunately, phase 3 data (ECHO-301) suggests that the combo gives no benefit to progression-free survival (PFS) in metastatic melanoma when compared to Keyruda monotherapy. This has led to the trial being halted and elevated concerns on whether IDO1 is an effective immune-oncology target. This unfortunate result has led to a huge drop (over 20%) in Incyte’s share value where they now have a difficult job to rebuild confidence for the hopeful blockbuster future. If this story interests you, please read the Endpoints article here.
Chinese policy has taken a big step towards promoting generic over branded medicines. New policy states that certain generic companies may be eligible to be designated as a high-tech enterprise which would mean they face just 15% corporate tax rate rather than the 25% faced by other companies. On top of this, physicians will not be able to write brand name prescriptions other than in special circumstances, and even then, a pharmacist can change it to the qualified generic. The country’s State Council have also issued a decree that intellectual property protections will be altered to strengthen anti-monopoly enforcement. Each of these steps further diminish innovator drug candidate values, posing a possible threat to foreign innovative drug makers. Please click on this FiercePharma article to read more.