The FDA Friday gave a faster-than-expected nod to Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib), an oral proteasome inhibitor expected to eventually replace blockbuster Velcade (bortezomib), which is set to lose patent protection later this decade.
Osaka, Japan-based Takeda had submitted the new drug application a mere four months ago. The FDA accepted the application in September, granting priority review.
Ninlaro in indicated for use in combination with Revlimid (lenalidomide) and dexamethasone to treat multiple myeloma patients who have received at least one prior therapy. Its approval was based on data from the 722-patient TOURMALINE-MM1 study, which pitted the triple-drug combination featuring Ninlaro against lenalidomide, dexamethasone and placebo. Those in the Ninlaro arm had a longer progression-free survival rate vs. those on the control arm (20.6 months vs. 14.7 months).
Though it's not the first proteasome inhibitor on the block – Ninlaro will be competing in the same space as Velcade and Kyprolis (carfilzomib, Amgen Inc.) – its once-weekly, oral administration is expected to be its primary advantage. For Takeda, that will be even more important when Velcade goes off patent, now expected to happen in 2017 following a District Court ruling in August that invalidated the patent that would have kept Velcade generics at bay until 2022.
According to Cortellis Competitive Intelligence, worldwide Velcade sales totaled about $1.6 billion in 2014.
Ninlaro's approval marked the second FDA nod in less than a week in the multiple myeloma space. On Monday, the agency granted accelerated approval to Genmab A/S's anti-CD38 antibody, Darzalex (daratumumab) injection, for use as a single agent to treat patients who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory (IMiD) agent or who are double-refractory to a proteasome inhibitor and an IMiD agent. (See BioWorld Today, Nov. 17, 2015.)
Ninlaro is under review at the EMA for the treatment of patients with relapsed and/or refractory multiple myeloma.. It was granted accelerated assessment by the Committee for Medicinal Products for Human Use in July.
The drug also is in late-stage testing in several other studies, including TOURMALINE-MM2, which is evaluating Ninlaro plus lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients, and TOURMALINE-MM3, which is testing the drug as maintenance therapy in newly diagnosed patients following induction therapy and autologous stem cell transplant. The TOURMALINE-AL1 study is testing Ninlaro plus dexamethasone in patients with relapsed or refractory AL amyloidosis, an indication for which the drug previously received orphan designation.