This month's products include oral paclitaxel, pralsetinib, azacitidine, and more.
FLUTICASONE FUROATE, UMECLIDINIUM, VILANTEROL (TRELEGY ELLIPTA)MARKETED BY: GlaxoSmithKline and Innoviva
The FDA recently approved the combination therapy fluticasone furoate, umeclidinium, and vilanterol inhalation powder for the treatment of asthma in patients age 18 years and older, following its approval for use in chronic obstructive pulmonary disease (COPD). The approved strength for both asthma and COPD is 100/62.5/25 mcg, with an additional strength for asthma alone of 200/62.5/25 mcg. The approval marks the first single inhaler triple therapy available for both asthma and COPD and is the only option available for patients in a convenient once-daily inhalation.
FOR MORE INFORMATION: trelegy.com
ORAL PACLITAXEL, ENCEQUIDARMARKETED BY: Athenex
The FDA has accepted Athenex’s new drug application (NDA) for oral paclitaxel and encequidar and recently granted a priority review for the investigational treatment, indicated for metastatic breast cancer. The NDA submission is based on a single phase 3 study, which found a statistically significant improvement in the overall response rate, as well as lower neuropathy among patients who received oral paclitaxel. The oral option may also be important for patients during the coronavirus disease 2019 (COVID-19) pandemic, as it would allow them to receive treatment without going to a clinic or hospital.
FOR MORE INFORMATION: athenex.com
PRALSETINIB (GAVRETO)MARKETED BY: Blueprint Medicines Corporation
The FDA recently approved pralsetinib for the treatment of adults with metastatic RET fusion—positive non– small cell lung cancer (NSCLC), a rare form of lung cancer affecting just 1% to 2% of patients with NSCLC. It is a once-daily oral precision therapy that selectively targets RET alterations, including fusions and mutations, which are key in many cancer types. In the phase 1/2 ARROW study (NCT03037385), pralsetinib demonstrated an overall response rate of 57% and complete response rate of 5.7% among the 87 participants with NSCLC who were previously treated with platinum-based chemotherapy.
FOR MORE INFORMATION: blueprintmedicines.com
AZACITIDINE (ONUREG)MARKETED BY: Bristol Myers Squibb
The FDA has approved azacitidine in 300-mg tablets for the continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. The approval was based on a phase 3 study that showed significantly improved overall survival (OS) at the primary end point of almost 10 months. The median OS time was 24.7 months from the time of randomization for those receiving azacitidine.
FOR MORE INFORMATION: bms.com