One new approval last week and some big news on two budget busters.
In a 507-patient, Phase III trial, Aveo Oncology’s tivozanib demonstrated improved progression-free survival, but not overall survival compared to sorafenib in patents with renal cancer. Tivozanib was similar to bevacizumab in colorectal cancer but did not show a benefit for breast cancer. Aveo announced that in a 27 patient, Phase Ib/II trial, data from 14 patients treated with tivozanib in combination with nivolumab suggested a partial response in 9 patients and 5 patients with disease stabilization. In a 161 patient, Phase III trial, advanced renal cell carcinoma patients that had been treated with sorafenib were changed to treatment with tivozanib and had a PFS of 11 months and overall survival of 22 months. Aveo announced that in the 351-patient, Phase III TIVO-3 trial, patients treated with tivozanib had a median progression-free survival of 5.6 months compared to 3.9 months with sorafenib in patients with highly refractory advanced or metastatic renal cell carcinoma that had failed at least two prior therapies, including a vascular EGFR TKI. A checkpoint inhibitor had been used in 26% of patients. Tivozanib has an FDA Orphan Drug priority designation.
The FDA has granted Fast Track designation to Karyopharm Therapeutics’ selinexor in addition to its Orphan Drug priority designation. Selinexor is intended to treat patients with diffuse large B-cell lymphoma. The drug has an April 6, 2019, PDUFA Date.
Mallinckrodt announced that in a 52-week, Phase II/III trial, VTS-270 was no better than placebo in treating Niemann-Pick type C. Mallinckrodt obtained VTS-270 when it bought Sucampo Pharmaceuticals in 2017.
Biomarin plans to file an NDA for valoctocogene roxaparvovec in the second half of 2019.
In a 58 patient, Phase II trial, 57% of patients treated with Jiangsu Chiatai Qingjiang/Advenchen’s anlotinib had a partial response and 85.5% of patients had a progression-free survival of 48 weeks in patients with advanced or metastatic medullary thyroid carcinoma.
The European Medicines Agency accepted the MAA for Ambit Biosciences Corporation/Daiichi Sankyo’s quizartinib and granted accelerated assessment for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive. The FDA has granted Orphan Drug, Breakthrough Therapy and Fast Track priority designations to quizartinib.
AveXis indicated it may price AVXS-101 at $4 million or more for the single dose treatment of spinal muscular atrophy.
Sage announced it will price brexanolone between $20,000 and $35,000 per course of treatment. At least one analyst estimates that rebates will bring the price down to $14,000. Due to the risk of dizziness and loss of consciousness, Sage indicated that brexanolone will likely be approved with a REMS program requiring administration and monitoring in a healthcare setting with REMS program certified staff. Sage forecasts availability in March 2019 and will initially focus its sales force on hospitals that are able to meet REMS requirements.
The FDA approved revefenacin inhalation solution (Yupelri, Mylan Pharmaceuticals, Theravance Biopharma) on 11/9/18 for the maintenance treatment of patients with COPD. Yupelri is the first muscarinic receptor antagonist that is available as a nebulized solution.
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