On Dec. 2, the FDA’s Oncologic Drugs Advisory Committee will review two accelerated approvals from Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, as a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years.
Secura Bio, Inc. (www.securabio.com), an integrated, commercial-stage biopharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies, today announced that it has acquired the global rights to Farydak® (panobinostat) from Novartis.
The Johnson & Johnson (J&J) unit's first-in-class anti-CD38 antibody was given conditional approval in the EU last May as a monotherapy after both the two standard therapies - Celgene's Revlimid (lenalidomide) plus dexamethasone and Takeda's Velcade (bortezomib) plus dexamethasone - have already been tried.
In its first drug index, consultancy firm Trinity Partners analyzed three years of data on drugs approved by the FDA back in 2013, ranking them 1 through 22 after considering “commercial success relative to therapeutic value and R&D effort.”
U.S. prices for newer multiple myeloma cancer treatments should be cut by as much as 94 percent to justify their value in terms of prolonging life, while there is not enough evidence to assess the benefit of some, according to an independent nonprofit organization that evaluates the effectiveness of medicines.
The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Empliciti (elotuzumab) for use in combination with Celgene's Revlimid (lenalidomide) and corticosteroid drug dexamethasone as a second-line therapy for multiple myeloma patients.
The National Institute for Health and Care Excellence has issued final recommendations endorsing National Health Service use of new therapies for ovarian cancer, multiple myeloma and prostate cancer, but rejecting one for gastric cancer.
The US FDA has cleared Ash Stevens to make the API for Takeda's new multiple myeloma drug Ninlaro, which is the first oral proteasome inhibitor to be approved in the country.
Takeda Pharmaceutical's top cancer prospect won a speedy FDA approval, wading into a crowded market for multiple myeloma treatments with hopes of duplicating the success of Velcade.