FDA Approves First Generics of Gilotrif (afatinib) Tablets

Afatinib works by irreversibly blocking ErbB family receptors (including EGFR, HER2, etc.), shutting down cancer cell signaling pathways and inhibiting tumor growth.

Gipritinib is a potent, selective, oral FMS-like tyrosine kinase 3 (FLT3) inhibitor. The approval of gipritinib was based on the global, multicenter, open-label, randomized, controlled phase III clinical trial ADMIRAL, which ultimately enrolled 371 patients with relapsed or refractory AML who had FLT3 mutations detected in their blood or bone marrow. These patients were randomized 2:1 to receive either gipritinib or salvage chemotherapy. The primary composite endpoint of the ADMIRAL study was overall survival (OS) and the rate of complete remission (CR/CRh) with complete or partial hematologic recovery. The results of this study were published in the prestigious medical journal *The New England Journal of Medicine* (NEJM).

Eltrombopag is a thrombopoietin receptor agonist that works by inducing the differentiation and proliferation of megakaryocytes (particularly large cells found in the bone marrow). It is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have not responded adequately to glucocorticoids, immunoglobulins, or splenectomy. Currently, eltrombopag is approved in more than 100 countries worldwide for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), and in 43 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C (CHC) to initiate and maintain standard interferon-based therapies for liver disease.

Eltrombopag is a thrombopoietin receptor agonist that works by inducing the differentiation and proliferation of megakaryocytes (particularly large cells found in the bone marrow). It is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have not responded adequately to glucocorticoids, immunoglobulins, or splenectomy. Currently, eltrombopag is approved in more than 100 countries worldwide for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), and in 43 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C (CHC) to initiate and maintain standard interferon-based therapies for liver disease.

Selinexor (ATG-010) was approved for marketing by the U.S. Food and Drug Administration (FDA) in 2019. Selinexor blocks the nuclear export of tumor suppressor, growth regulator, and anti-inflammatory proteins by binding to the nuclear export protein XPO1 (CRM1), promoting the accumulation of these proteins in the cell nucleus and enhancing their anti-cancer activity in cells.

Lorlatinib is a third-generation drug for the treatment of non-small cell lung cancer (NSCLC). It exhibits strong inhibitory activity against both anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) receptor tyrosine kinase (RTK). It is used to treat patients who have previously received at least one ALK inhibitor, such as the first-generation ALK inhibitor crizotinib or the second-generation ALK inhibitor crizotinib...