The European Commission approved a subcutaneous formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma.
Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche’s oncology products using Halozyme’s patented Enhanze (recombinant human hyaluronidase) technology.
The European approval was primarily based on data from the pivotal SABRINA study, which was recently published in the Lancet Oncology. Roche has stated that they expect to begin launching MabThera SC in a number of European markets throughout 2014.
The Japan Ministry of Health, Labor and Welfare granted approval to the Lonsurf combination tablet T15 and T20 (trifluridine and tipiracil hydrochloride), for the treatment of patients with unresectable advanced or recurrent colorectal cancer, if refractory to standard therapies.
Japan is the first country in the world to grant marketing authorization for Lonsurf, according to Taiho Pharmaceutical Company Ltd., the drugs’ sponsor. The approval is based primarily on the results of a randomized, double blind placebo controlled phase II clinical trial conducted in Japan (J003-10040030). Taiho is conducting a global phase III clinical trial, named RECOURSE, on patients with metastatic colorectal cancer refractory to standard chemotherapies.
Lonsurf is a combination drug of trifluridine and tipiracil hydrochloride. Trifluridine is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. Its blood concentration is maintained via tipiracil hydrochloride.
The United Kingdom’s National Institute for Health and Care Excellence published its final guidance recommending prescription of Pixuvri (pixantrone) as a cost-effective monotherapy for the treatment of adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma.
Publication of the final guidance by NICE follows the final appraisal determination issued in January 2014. The National Health Service is expected to implement the guidance within 60 days.
Pixuvri, sponsored by Cell Therapeutics Inc., is a novel aza-anthracenedione that forms stable DNA adducts and is designed to not bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite—both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity.
The Microbiology Devices Panel of the FDA Medical Devices Advisory Committee unanimously recommended that the benefits of the cobas HPV Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the test is safe and effective for the proposed indication for use.
If approved, the test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the U.S.
The cobas HPV Test, developed by Roche, is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run from one patient sample.
The cobas HPV Test received FDA approval in April 2011 for screening patients age 21 and older with abnormal cervical cytology results and for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes.
FDA approved revised prescribing information for the use of Thyrogen (thyrotropin alfa for injection) to widen the dose range of radioiodine when used for thyroid remnant ablation.
Thyrogen, sponsored by Genzyme, a Sanofi company, is used before radioiodine treatment to enhance uptake of the radiotracer and allows patients to start and continue taking their thyroid hormone replacement therapy, avoiding the untoward effects associated with hypothyroidism. Previously the amount of radioiodine was fixed at 100 mCi—physicians may now select a dose from the range of 30-100 mCi.
The revised prescribing information is based on the results of the two largest prospective studies ever conducted in thyroid cancer. The studies, published in the New England Journal of Medicine in May 2012, compared ablation success among patients receiving recombinant human thyrotropin and patients undergoing thyroid hormone withdrawal at both low and high doses of radioiodine. In both studies, patients receiving Thyrogen rather than THW had fewer hypothyroid symptoms and preserved quality of life.
Thyrogen is approved as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging. Thyrogen is also approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
Mylan Inc. and its subsidiary, Mylan Pharmaceuticals Private Limited, launched the world’s first Herceptin biosimilar in India.
The product, which will be marketed by Mylan under the brand name Hertraz, is a biosimilar to Roche’s Herceptin (trastuzumab). Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in, 440 mg and 150 mg.
Hertraz was approved by the Drug Controller General of India. In support of this approval, Mylan conducted a series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin. These analytical methodologies confirmed the high degree of molecular similarity as well as biological activity of Hertraz. In addition, Mylan conducted a multi-center clinical trial to demonstrate comparable safety and efficacy to the reference product.
Mylan has exclusive commercialization rights for biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.
Neogenomics Inc. launched a series of NeoTYPE cancer profiling tests covering 22 different categories of cancer.
The 22 categories of tumors covered in this series of tests are: brain, lung, breast, cervix, colorectal, endometrium, esophagus, stomach, ovary, soft tissue, thyroid, GIST, melanoma, acute myeloid leukemia, myelodysplastic syndrome, AML favorable-risk, chronic lymphocytic leukemia, lymphoma, juvenile myelomonocytic leukemia, myeloproliferative neoplasms, cancer not-otherwise specified, and spliceosomal abnormalities.
The genetic abnormalities are investigated using sequencing, fluorescent in-situ hybridization, methylation analysis, fragment length analysis, and SNP-cytogenetic array technology. Although more than 60 different genes are investigated in all these tumors, only 8-18 genes are investigated per patient or tumor type.
Clarient added the THxID-BRAF molecular diagnostic test, developed by BioMerieux Inc., to its service offerings.
Clarient, a GE Healthcare Company, will use the test to aid oncologists in selecting metastatic melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s Tafinlar (dabrafenib) as well as in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist (trametinib).
The companion diagnostic assay received PMA approval from the FDA in May 2013.
FDA granted clearance to a phase III trial of ThermoDox in hepatocellular carcinoma, named OPTIMA. The study is expected to launch in the first half of this year.
ThermoDox, developed by Celsion Corporation, is a heat-activated liposomal encapsulation of doxorubicin used in combination with radio frequency ablation.
The trial design is based on an analysis of data from the phase III HEAT Study, which demonstrated that treatment with ThermoDox resulted in a 55 percent improvement in overall survival in a substantial number of HCC patients that received an optimized RFA treatment.
The trial is expected to enroll 550 patients globally, at up to 100 sites. The primary endpoint for the trial is overall survival, and the statistical plan calls for two interim efficacy analyses by an independent data monitoring committee.
