42-26 FDA Approves Epclusa For Adults with Chronic Hepatitis C

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Drugs and Targets

FDA Approves Epclusa For Adults with Chronic Hepatitis C

FDA approved Epclusa to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis, Epclusa is approved for use in combination with the drug ribavirin.

Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

The safety and efficacy of Epclusa for 12 weeks was evaluated in three phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis. Results demonstrated that 95-99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with moderate to severe cirrhosis, of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.

Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

FDA granted a fourth Breakthrough Therapy Designation to Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease after failure of one or more lines of systemic therapy. The agency also granted the therapy Orphan Drug Designation for the condition.

The request was based on preliminary clinical data from a phase Ib/II study evaluating the safety and efficacy of Imbruvica for the treatment of patients with steroid-dependent or refractory cGVHD. Overall, Imbruvica has shown compelling preclinical data, a novel mechanism of action and promising early clinical efficacy data supporting an improvement in cGVHD based on the NIH consensus cGVHD Activity Assessment. Preliminary results from this trial were previously presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation in April and the 51st American Society of Clinical Oncology annual meeting in May 2015. Imbruvica is sponsored by AbbVie.

FDA granted Fast Track Designation to ets-family inhibitor TK216 in Ewing sarcoma patients that have relapsed or are refractory to standard of care therapy.

Oncternal Therapeutics Inc., the drug’s sponsor, is in the process of initiating a first-in-human phase I trial in relapsed or refractory Ewing sarcoma.

TK216 is a first-in-class small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins in a variety of tumor types, stopping cancer cell growth and tumor formation, according to the company. In Ewing sarcoma, it is designed to target a single and well-characterized genetic mutation that causes the disease.

Hetero launched a biosimilar of bevacizumab in India for the treatment of metastatic colorectal cancer under the brand name Cizumab.

The product has been approved by the drug controller general of India and has been recommended as a first-line treatment for mCRC. The product will be made available to patients in a single dose vial with two strengths, 100 mg and 400 mg. It will be marketed and distributed by Hetero Healthcare Ltd.

Novartis entered into a collaboration and license agreement with Xencor Inc. to develop and commercialize novel therapeutics, including XmAb 14045 for acute myeloid leukemia, and XmAb 13676 for B-cell malignancies. Both are expected to begin development this year.

Under the terms of the agreement, the parties will collaborate and share development costs for the worldwide development of XmAb14045 and XmAb13676, with Xencor maintaining U.S. commercialization rights and Novartis having commercialization rights in the rest of the world. Novartis will receive worldwide rights to Xencor’s bispecific technology to develop and commercialize four additional targets selected by Novartis, one of which Xencor may elect to co-detail in the U.S. The bispecific collaboration will include molecular engineering by Xencor. Additionally, Novartis will receive a worldwide non-exclusive license to use Xencor’s XmAb Fc technologies in up to ten molecules. Xencor will receive a $150 million upfront payment and is eligible to receive clinical, regulatory and sales milestone payments for successful programs.

OmniSeq, a subsidiary of Roswell Park Cancer Institute, received New York State Clinical Laboratory Evaluation Program approval for its OmniSeq Comprehensive panel, a 144 gene, pan-cancer, next-generation sequencing tumor profiling diagnostic panel to guide oncology treatment decision-making.

“OmniSeq is proud to receive New York State CLEP approval for OmniSeq Comprehensive. CLEP is the highest standard of Clinical Laboratory Improvement Amendments laboratory validation,” said Carl Morrison, president and chief scientific officer of OmniSeq and executive director of the Roswell Park Center for Personalized Medicine.


President Joe Biden’s proposed Advanced Research Projects Agency-Health would be a welcome partner to NCI—particularly in conducting large, collaborative clinical investigations, NCI Director Ned Sharpless said.“I think having ARPA-H as part of the NIH is good for the NCI,” Sharpless said April 11 in his remarks at the annual meeting of the American Association for Cancer Research. “How this would fit with the ongoing efforts in cancer at the NCI is still something to work out.”