41-35 FDA Approves Varubi for Chemotherapy-Induced Nausea

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FDA Approves Varubi for Chemotherapy-Induced Nausea

FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting.

Varubi is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of emetogenic and highly emetogenic cancer chemotherapy.

Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase.

Varubi is provided to patients in tablet form.

The safety and efficacy of Varubi were established in three randomized, double-blind, controlled clinical trials where Varubi in combination with granisetron and dexamethasone was compared with a placebo in 2,800 patients receiving a chemotherapy regimen that included highly emetogenic (such as cisplatin and the combination of anthracycline and cyclophosphamide) and moderately emetogenic chemotherapy drugs.

Patients treated with Varubi had a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase compared to those receiving the control therapy.

Varubi inhibits the CYP2D6 enzyme, which is responsible for metabolizing certain drugs.

Varubi is contraindicated with the use of thioridazine, a drug metabolized by the CYP2D6 enzyme, because use of the two drugs together may increase the amount of thioridazine in the blood and cause an abnormal heart rhythm that can be serious.

Varubi is marketed by Tesaro Inc. of Waltham, Mass.

Amgen’s supplemental new drug application for Kyprolis (carfilzomib) in relapsed multiple myeloma was granted priority review by FDA.

Amgen said FDA has accepted for priority review the supplemental new drug application (sNDA) of Kyprolis (Carfilzomib) for injection for patients with relapsed multiple myeloma.

The sNDA is designed to expand the current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy.

Application based on phase 3 head-to-head trial showing superiority of Kyprolis and dexamethasone over bortezomib plus dexamethasone.

The FDA’s acceptance of the sNDA for Kyprolis follows the recent FDA approval for Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.

The application is based on data from the phase 3 head-to-head ENDEAVOR study, which showed that patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over bortezomib and low-dose dexamethasone (median progression-free survival [PFS] 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65; p<0.0001).

Treatment discontinuation due to adverse events and on-study deaths was comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study.

In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the bortezomib arm. There was also an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to bortezomibin ENDEAVOR.

The Prescription Drug User Fee Act target action date is Jan. 22, 2016.

Roche NimbleGen introduced an enhanced whole exome sequencing solution for medical and translational research.

Roche announced the global launch of the SeqCap EZ MedExome Target Enrichment Kit, a comprehensive whole exome sequencing solution designed to increase the discovery and detection of human genetic variants associated with disease while reducing sequencing costs.

Pekka Ellonen, head of the sequencing unit for the Institute for Molecular Medicine Finland at the University of Helsinki, said, “We have evaluated a number of target enrichment systems for whole exome sequencing.

The kit is labeled “for research use only. It isn’t approved for diagnostic procedures.

CTI BioPharma Corp. said it plans to submit a new drug application to FDA following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R.

The company expects to submit the NDA in the fourth quarter of 2015 and to request faster approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter.

The NDA will be based primarily on data from the PERSIST-1 phase 3 trial – as well as data from Phase 1 and 2 studies of pacritinib – and additional information requested by FDA, including a separate study report and datasets for the specific patient population with low platelet counts of less than 50,000 per microliter for whom there are no approved drugs.

Submission of an NDA after a single phase 3 trial under accelerated approval, instead of waiting to complete two phase 3 trials, could potentially reduce time to market by up to 14 months.

Amgen Inc. and Xencor Inc. entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation.

The research collaboration brings together Amgen’s capabilities in target discovery and protein therapeutics with Xencor’s XmAb bispecific technology platform.

The collaboration includes molecular engineering by Xencor and the preclinical development of bispecific molecules for five programs proposed by Amgen, leveraging XmAb bispecific Fc domains to make half-life extended T cell engagers and dual targeting bispecific antibodies.

The agreement also includes a preclinical bispecific T cell engager program directed at CD38 and CD3 for multiple myeloma.

Amgen will be fully responsible for preclinical and clinical development and commercialization worldwide. Under the agreement, Xencor will receive a $45 million upfront payment and up to $1.7 billion in clinical, regulatory and sales milestone payments in total for the six programs.

Xencor is eligible to receive mid to high single-digit royalties for candidates directed against Amgen’s targets, and high single to low double-digit royalties for Xencor’s CD38 bispecific T cell engager.

Bispecific technologies seek to engineer monoclonal antibodies to bind two unique drug targets, as opposed to traditional antibodies designed to bind to a single antigen target.

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