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Weekly Drug News Round-Up: May 3, 2017

AstraZeneca’s Imfinzi Cleared for Advanced Bladder Cancer

Imfinzi is an anti-PD-L1 blocker, also called an immune checkpoint inhibitor Read More...

Imfinzi (durvalumab) has now been FDA-approved for the treatment of patients with advanced urothelial carcinoma who have disease progression despite use of platinum-containing chemotherapy with or without surgery. Imfinzi is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody in the same class of drugs as Tecentriq (atezolizumab) and Bavencio (avelumab). In studies, Imfinzi had an objective response rate (ORR) of 17%, regardless of PD-L1 status, with an ORR of 26.3% in patients with PD-L1 high-expressing tumors. Among 31 patients who responded to treatment, 14 patients (45%) had ongoing responses of at least 6 months and 5 patients (16%) at least 12 months. Of all evaluable patients, 2.7% achieved complete response.

Takeda Announces FDA Accelerated Approval of Alunbrig

Alunbrig is a once-daily oral therapy that may be taken with or without food Read More...

The US Food and Drug Administration (FDA) has approved Alunbrig (brigatinib) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Xalkori (crizotinib). In the pivotal Phase 2, open-label ALTA study which enrolled 222 patients, the overall response rate after a median follow up of 8 months at the recommended dosing was 53 to 54 percent, and the median duration of response ranged from 11.1 to 13.8 months. The most common adverse reactions (≥25%) with Alunbrig were nausea, diarrhea, fatigue, cough, and headache.

Tymlos Cleared for Treatment of Osteoporosis

Tymlos, from Radius Health, will be commercially available in June Read More...

Roughly 2 million osteoporotic fractures occur annually in the U.S., and this number is expected to grow to 3 million by 2025. The US Food and Drug Administration (FDA) has approved Tymlos (abaloparatide), a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. In the ACTIVE trial, Tymlos demonstrated significant reductions in the relative risk of new vertebral and nonvertebral fractures compared to placebo of 86% in new vertebral fractures and 43% in nonvertebral fractures. Warnings include formation of osteosarcoma (a malignant bone tumor) in animals.

Rydapt Approved for Acute Myeloid Leukemia and Systemic Mastocytosis

Rydapt is a kinase inhibitor that works by blocking several enzymes that promote cell growth Read More...

Rydapt (midostaurin), a new oral targeted drug from Novartis, has been FDA-approved for 2 uses: acute myeloid leukemia (AML) in combination with chemotherapy for adults with an FMS-like tyrosine kinase-3 (FLT3) mutation as diagnosed by a special test, and for advanced systemic mastocytosis (SM). AML is an aggressive bone marrow cancer and systemic mastocytosis (SM) includes several rare blood disorders. Side effects differ slightly between uses but can include nausea, vomiting, low levels of white blood cells with fever (febrile neutropenia), muscle pain, or upper respiratory tract infection, among others.

FDA Approves Brineura for CLN2 Disease, a Form of Batten Disease

Individuals often require the use of a wheelchair by late childhood and typically do not survive past their teens Read More...

Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a form of Batten disease, is a rare inherited disorder that primarily affects the nervous system. Batten disease typically begins between the ages of 2 and 4 with symptoms such as language delay, recurrent seizures (epilepsy) and difficulty coordinating movements (ataxia). For treatment, the FDA has approved Brineura (cerliponase alfa), from BioMarin Pharmaceutical, for this specific form of Batten disease. Brineura is an enzyme replacement therapy for tripeptidyl peptidase-1 (TPP1). It's the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic children 3 years of age and older with CLN2.