News

olaparib

Posted on 8.18.2017

U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based … Read More

inotuzumab

Posted on 8.18.2017

U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).… Read More

ibrutinib

Posted on 8.14.2017

U.S. Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for … Read More

enasidenib

Posted on 8.14.2017

U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.… Read More

Neratinib (Nerlynx)

Posted on 7.19.2017

U.S. Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.… Read More

FDA Tackles Drug Competition to Improve Patient Access

Posted on 6.27.2017

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved … Read More

Dabrafenib and Trametinib (Tafinlar® and Mekinist®)

Posted on 6.26.2017

U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (TAFINLAR® and MEKINIST®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.… Read More

Rituximab and Hyaluronidase Human (Rituxan Hycela)

Posted on 6.23.2017

FDA granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.… Read More

Osimertinib (Tagrisso)

Posted on 6.15.2017

U.S. Food and Drug Administration granted regular approval to osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals, LP) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose … Read More

Ceritinib (Zykadia)

Posted on 5.30.2017

FDA granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.… Read More