Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

In July 2018 durvalumab (Imfinzi ®) received a positive opinion from the Committee for Medical Products for Human Use (CHMP). The committee recommended marketing authorisation for the agent in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells, and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. [1] Continue reading “Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe”

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®) was approved by the Japanese Ministry of Health, Labour and Welfare in July 2018, for maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).[1] Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan”

Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC

Anlotinib (Focus V®): First Global Approval – single-drug  3rd-line therapy for patients with advanced recurrent NSCLC

The recent first global approval of anlotinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In May 2018, anlotinib (Focus V®), co-developed by Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories, received its first global approval in China as a single drug therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy.  Continue reading “Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC”

Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA

Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA

In February 2018, durvalumab (IMFINZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy.[1] Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA”

Brigatinib (ALUNBRIG™): First Global Approval – resistance is futile in the battle against metastatic NSCLC

Brigatinib (ALUNBRIG™): First Global Approval –  resistance is futile in the battle against metastatic NSCLC

The recent first global approval of brigatinib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Brigatinib (ALUNBRIG™): First Global Approval – resistance is futile in the battle against metastatic NSCLC”