OncLive Global

Novartis Signs In-Licensing Agreement With BeiGene to Expand Tislelizumab Trials Globally

January 26th 2021

January 26, 2021 - Novartis has signed a strategic collaboration agreement to in-license the PD-1 inhibitor tislelizumab from BeiGene, Ltd, in various markets outside of China.

Frontline Pembrolizumab Approved in Europe for Metastatic MSI-H/dMMR CRC

January 26th 2021

January 26, 2021 - The European Commission has approved single-agent pembrolizumab for use in the frontline treatment of patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

Toripalimab Granted FDA Fast Track Status for Mucosal Melanoma

January 25th 2021

January 25, 2021 - The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.

Acalabrutinib Approved in Japan for Relapsed/Refractory CLL

January 25th 2021

January 25, 2021 - The Japanese Ministry of Health, Labour and Welfare approved the BTK inhibitor acalabrutinib for use in adult patients with relapsed/refractory chronic lymphocytic leukemia, including small lymphocytic lymphoma

Avelumab Approved in Europe for Frontline Maintenance in Metastatic Urothelial Carcinoma

January 25th 2021

January 25, 2021 - The European Commission has approved avelumab for use as a frontline maintenance option in the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who did not progress after having received platinum-based chemotherapy.

Axicabtagene Ciloleucel Approved in Japan for Relapsed/Refractory LBCL

January 22nd 2021

January 22, 2021 — The Japan Ministry of Health, Labour and Welfare has approved the CAR T-cell therapy axicabtagene ciloleucel for use in the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas.

Trastuzumab Deruxtecan Approved in Europe for HER2+ Metastatic Breast Cancer

January 20th 2021

January 20, 2021 - The antibody-drug conjugate trastuzumab deruxtecan has been granted conditional approval in the European Union for use as a single agent in the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more HER2-based regimens.

Fixed-Dose Durvalumab Approved in Europe for Unresectable NSCLC

January 15th 2021

January 15, 2021 - Durvalumab has been approved in the European Union and the United Kingdom for a fixed-dose option of 1,500 mg every 4 weeks for use in patients with locally advanced, unresectable non–small cell lung cancer whose tumors have a PD-L1 expression of at least 1% and who have not experienced disease progression after platinum-based chemoradiation treatment.

Sintilimab Injection Second-Line Squamous NSCLC Application Accepted in China

January 14th 2021

January 14, 2020 — The National Medical Products Administration of China has accepted a supplemental new drug application for sintilimab injection for use in the second-line treatment of patients with squamous non–small cell lung cancer.

Frontline Tislelizumab/Chemo Approved in China for Advanced Squamous NSCLC

January 14th 2021

January 14, 2020 - The China National Medical Products Administration has approved tislelizumab for use in combination with 2 chemotherapy regimens in the frontline treatment of patients with advanced squamous non–small cell lung cancer.

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