publication date: Jun. 12, 2020
Drugs & Targets
Nivolumab approved by FDA for esophageal squamous cell carcinoma
Opdivo (nivolumab) was approved by FDA for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Efficacy was investigated in ATTRACTION-3 (NCT02569242), a multicenter, randomized (1:1), active-controlled, open-label trial in 419 patients with unresectable advanced, recurrent, or metastatic ESCC. Patients who were refractory or intolerant to at least one fluoropyrimidine- and platinum‑based regimen received nivolumab 240 mg by intravenous infusion over 30 minutes every 2 weeks (n=210), or investigator’s choice of taxane chemotherapy consisting of docetaxel (75 mg/m2 intravenously every 3 weeks) or paclitaxel (100 mg/m2 intravenously once a week for 6 weeks followed by 1 week off) (n=209).
The major efficacy outcome measure was overall survival. Additional efficacy outcome measures were overall response rate, response duration, and progression-free survival as assessed by the investigator using RECIST 1.1.
The trial demonstrated a statistically significant improvement in OS. Median OS for patients receiving nivolumab was 10.9 months (95% CI: 9.2, 13.3) compared with 8.4 months (95% CI: 7.2, 9.9) for patients receiving investigator’s choice of taxane chemotherapy (HR: 0.77; 95% CI: 0.62, 0.96; p=0.0189). OS benefit was observed regardless of tumor PD-L1 expression level. The ORR was 19.3% (95% CI: 13.7, 26) in the nivolumab arm versus 21.5% (95% CI: 15.4, 28.8) in the taxane chemotherapy arm, with median response duration of 6.9 months (95% CI: 5.4, 11.1) and 3.9 months (95% CI: 2.8, 4.2), respectively. The trial did not demonstrate an improvement in PFS (HR: 1.1; 95% CI: 0.9, 1.3).
Supportive care biosimilar Nyvepria approved by FDA
Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim), received FDA approval.
Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Nyvepria is sponsored by Pfizer.
The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.
Berubicin receives FDA Orphan Drug status for gliomas
Berubicin was granted Orphan Drug Designation by FDA for the treatment of malignant gliomas.
Berubicin is sponsored by CNS Pharmaceuticals Inc.
In the phase I trial of Berubicin to treat glioblastoma under a prior developer, 44% of the patients demonstrated a significant improvement in progression-free survival, and one patient experienced a complete response.