Drugs in the Pipeline

Drugs in the Pipeline

Investigational Pump Efficacious in Type 2 Diabetes Trials

Intarcia Therapeutics announced top-line results from two of its four Phase 3 clinical trials for ITCA 650 (continuously subcutaneous delivery of exenatide) for patients with type 2 diabetes.

ALK+ Metastatic NSCLC Therapy Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AP26113 (ARIAD Pharmaceuticals) for the treatment of anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

Investigational Sickle Cell Disease Agent Fast Tracked

The Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease.

Avedro Resubmits NDA for Eye Disorders

Avedro announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for riboflavin ophthalmic solution/KXL System for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

Adcetris Extends Survival in Post-Transplant Hodgkin Lymphoma Study

Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma.

Combination Breast Cancer Therapy Extends Overall Survival

Roche announced results from the Phase 3 CLEOPATRA study evaluating the addition of Perjeta (pertuzumab; Genentech) to Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy in patients with previously untreated HER2-positive metastatic breast cancer.

Cobimetinib + Zelborif Increased PFS in Melanoma Trial

Roche announced positive data from the coBRIM Phase 3 study with cobimetinib plus Zelboraf (vemurafenib) in patients with previously untreated BRAF V600 mutation-positive, advanced melanoma.

Phase 3 Results for Tafinlar in Mutant Metastatic Melanoma

GlaxoSmithKline announced updated results for Tafinlar (dabrafenib) from the Phase 3 BREAK-3 study in patients with BRAF V600E mutant metastatic melanoma.

FDA Grants Aldoxorubicin Orphan Drug Designation

The Food and Drug Administration (FDA) has granted multiple Orphan Drug designations to aldoxorubicin for glioblastoma multiforme, small cell lung cancer, and ovarian cancer.

Vesneo Reduces Intraocular Pressure in Trials

Bausch + Lomb announced positive results from the pivotal Phase 3 studies with Vesneo (latanoprostene bunod) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.