Drugs in the Pipeline

Lonafarnib Fast Tracked for Hepatitis Delta Virus Infection

The FDA has granted Fast Track designation to lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir for treatment of hepatitis delta virus (HDV) infection.

FDA Agrees to Review Adcetris for Post-Transplant Consolidation Therapy

The FDA has accepted for filing the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin; Seattle Genetics) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression.

sBLA Submitted for Additional Keytruda Indication

Merck announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC).

Biotin for Progressive Multiple Sclerosis: New Phase 3 Trial Data

MedDay announced results from its Phase 3 MS-SPI clinical trial with MD1003, a highly concentrated pharmaceutical-grade biotin for the treatment of progressive multiple sclerosis.

Results Halt Opdivo NSCLC Trial Early

Bristol Myers Squibb announced results from its Phase 3 CheckMate-057 study of Opdivo (nivolumab) vs. docetaxel in previously treated patients with advanced non-squamous cell lung cancer (NSCLC).

Samcyprone Designated Orphan Drug for Malignant Melanoma

The FDA has granted Orphan Drug designation to Samcyprone (diphenylcylcopropenone, DPCP; RXi Pharmaceuticals) for the treatment of malignant melanoma Stage IIb to IV.

Gencaro Fast Tracked for A-fib in Genetically Modified Heart Failure

The FDA has granted Fast Track designation to Gencaro (bucindolol HCl) for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction, [HFREF]).

Investigational RSV Therapy Granted Fast Track Status

MedImmune announced that the FDA has granted Fast Track designation to MEDI8897 for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children.

Grazoprevir/Elbasvir Designated Breakthrough Therapy for Chronic Hepatitis C

The FDA has granted Breakthrough Therapy designation to grazoprevir/elbasvir (Merck) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.

Fixed-Dose Combo HIV Drug Under FDA Review

Gilead Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for two doses of the fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infections in patients ≥12 years old, in combination with other HIV antiretroviral agents.

Lifitegrast for Dry Eye Disease Under FDA Review

The FDA has accepted for filing and granted Priority Review designation to the New Drug Application (NDA) for lifitegrast (Shire) for the treatment of signs and symptoms of dry eye disease in adults.

Ovarian Cancer Therapy Granted Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation to rucaparib (Clovis Oncology) as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.

FDA Accepts sNDA for New Pradaxa Indication

Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.

Progression-Free Survival With Encalutamide for Prostate Cancer: New Trial Results

Astellas Pharma and Medivation announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in men with non-metastatic or metastatic castration-resistant prostate cancer.

Anticogulant Reversal Agent Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to PER977 (Perosphere), an anticoagulant reversal agent.