OncLive Global

Denosumab Approved in China for Prevention of Skeletal-Related Events in Bone Metastases From Solid Tumors, Myeloma

November 23rd 2020

November 23, 2020 - The China National Medical Products Administration has approved denosumab for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in those with multiple myeloma.

FDA, EMA Approval Sought for Subcutaneous Daratumumab Plus Pomalidomide/Dexamethasone in Relapsed/Refractory Myeloma

November 12th 2020

Regulatory applications have been submitted to the FDA and the European Medicines Agency for subcutaneous daratumumab for use in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 previous therapy.

Enzalutamide Approved in China for Nonmetastatic Castration-Resistant Prostate Cancer

November 11th 2020

November 10, 2020 - The China National Medical Products Administration has approved enzalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at a higher risk of metastasis.

Acalabrutinib Approved in Europe for Chronic Lymphocytic Leukemia

November 10th 2020

November 10, 2020 - The European Union approved the next-generation BTK inhibitor acalabrutinib for use in adult patients with chronic lymphocytic leukemia.

Nivolumab/Ipilimumab Plus Chemo Approved in Europe for Frontline Metastatic NSCLC

November 6th 2020

The European Commission has approved the combination of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the up-front treatment of adult patients with metastatic non–small cell lung cancer without a sensitizing EGFR mutation or an ALK translocation.

Olaparib/Bevacizumab Approved in Europe for Frontline Maintenance in HRD+ Advanced Ovarian Cancer

November 5th 2020

The European Union has approved olaparib in combination with bevacizumab for use as a first-line maintenance treatment in patients with homologous recombination deficient–positive advanced ovarian cancer.

Atezolizumab/Bevacizumab Approved in Europe for Advanced or Unresectable HCC

November 2nd 2020

The European Commission has approved the combination of atezolizumab plus bevacizumab for use in adult patients with advanced or unresectable hepatocellular carcinoma who have not been given previous systemic therapy.

Atezolizumab Plus Bevacizumab Approved in China for Hepatocellular Carcinoma

October 30th 2020

The China National Medical Products Administration has approved the combination of atezolizumab plus bevacizumab for use in patients with unresectable hepatocellular carcinoma who have not received previous systemic therapy.

Niraparib Approved in Europe for Frontline Maintenance in Advanced Ovarian Cancer

October 29th 2020

The European Commission has approved niraparib for use as a frontline monotherapy maintenance option in adult patients with advanced epithelial, high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response after platinum-based chemotherapy.

Approval Sought for Cabozantinib/Nivolumab for Unresectable, Advanced, or Metastatic RCC in Japan

October 27th 2020

A supplemental application was submitted to the Japanese Ministry of Health, Labour, and Welfare for Manufacturing and Marketing approval of the combination of cabozantinib plus nivolumab for the treatment of patients with unresectable, advanced, or metastatic renal cell carcinoma.