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”

Baricitinib (Olumiant™): Now also available in the USA

Baricitinib (Olumiant™): Now also available in the USA

Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA);[1] this was followed shortly after by an approval in Japan in July of the same year.[2] Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018.[3] Continue reading “Baricitinib (Olumiant™): Now also available in the USA”

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

The recent first global approval of abemaciclib 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]. Continue reading “Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer”

Inotuzumab Ozogamicin (Besponsa®): First Global Approval – targeted treatment for Adults with relapsed or recurrent B-cell acute lymphoblastic leukaemia

Inotuzumab Ozogamicin (Besponsa®): First Global Approval – targeted treatment for Adults with relapsed or recurrent B-cell acute lymphoblastic leukaemia

The recent first global approval of inotuzumab ozogamicin 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]. Continue reading “Inotuzumab Ozogamicin (Besponsa®): First Global Approval – targeted treatment for Adults with relapsed or recurrent B-cell acute lymphoblastic leukaemia”

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

The recent first global approval of Baricitinib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, baricitinib (Olumiant™), developed by Eli Lily and Incyte Corporation, received its first global approval in the EU as monotherapy or in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment”