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Approved Drugs • Janssen Biotech, Inc. (janssenbiotech.com) cal will begin selling the once-a-day pill in announced that the FDA has granted the U.S. on Feb. 1, 2016. • The U.S. Food and Drug Administration accelerated approval to Darzalex™ (FDA) granted accelerated approval to ( injection) as a single • Millennium Pharmaceuticals (millennium. Alecensa® (alectinib) capsules (, agent for the treatment of patients with com) announced that the FDA has approved gene.com) for the treatment of patients with multiple myeloma who have received at Ninlaro® (ixazomib) in combination with anaplastic kinase (ALK)- least three prior lines of therapy, including lenalidomide and for the positive metastatic non-small cell lung a proteasome inhibitor (PI) and an immuno- treatment of patients with multiple cancer (NSCLC) who have progressed on or are modulatory agent, or who are double- myeloma who have received at least one intolerant to . Alecensa is an oral refractory to a PI and an immunomodula- prior therapy. Ixazomib is the first approved medication that blocks the activity of the ALK tory agent. oral proteasome inhibitor. protein, which may prevent NSCLC cells from growing and spreading. • The FDA approved Bristol-Myers Squibb’s • The FDA approved Bristol-Myers Squibb’s (bms.com) Empliciti™ (elotuzumab) in (bms.com) Opdivo® (nivolumab) Injection • Teva Pharmaceuticals Industries Ltd. combination with lenalidomide and for the treatment of advanced renal cell (tevausa.com) and Eagle Pharmaceuticals, Inc. dexamethasone for the treatment of carcinoma in patients who have received (eagleus.com) announced that the FDA has patients with multiple myeloma who have prior anti-angiogenic therapy. approved Bendeka™ (bendamustine received one to three prior therapies. hydrochloride) injection, a liquid, low- • Eli Lilly & Company (lilly.com) announced volume (50 ml) and short-time 10-minute • Merck (merck.com) announced that the that the FDA has granted approval to infusion formulation of bendamustine. FDA approved an expanded age indication Portrazza™ () in combina- Bendeka is approved for the treatment of for Gardasil®9 (Human Papillomavirus tion with gemcitabine and cisplatin for patients with chronic lymphocytic 9-valent Vaccine, Recombinant), Merck’s first-line treatment of patients with (CLL) and for the treatment of patients with 9-valent human papillomavirus (HPV) metastatic NSCLC. Necitumumab is not indolent B-cell non-Hodgkin lymphoma (NHL) vaccine, to now include use in males 16 indicated for treatment of non-squamous that has progressed during or within six through 26 years of age, for the prevention NSCLC. months of treatment with or a of anal cancer caused by HPV types 16, 18, 31, rituximab-containing regimen. Efficacy in CLL 33, 45, 52, and 58, precancerous or dysplastic • Novartis (novartis.com) announced that relative to first-line therapies other than lesions caused by HPV types 6, 11, 16, 18, 31, the FDA has granted regular approval for the chlorambucil has not been established. 33, 45, 52, and 58, and genital warts caused combination of Tafinlar® () + by HPV types 6 and 11. Mekinist® () for the treatment • The FDA has approved Genentech’s (gene. of patients with BRAF V600E/K mutation- com) Cotellic™ () for the • The FDA approved the first generic version positive unresectable or metastatic mela- treatment of people with BRAF V600E or of Gleevec® ( mesylate). The FDA noma as detected by an FDA-approved test. V600K mutation-positive unresectable or granted a subsidiary of Indian drug maker metastatic melanoma in combination with Sun Pharmaceutical Industries Ltd. approval • The FDA has approved AstraZeneca’s Zelboraf® (). Cotellic and Zelboraf to sell generic Gleevec in 100-milligram and (astrazeneca.com) Tagrisso™ (osimertinib) are not used to treat melanoma with a 400-milligram pills for chronic myeloid 80 mg once-daily tablets for the treatment normal BRAF gene. leukemia. Mumbai-based Sun Pharmaceuti- of patients with metastatic epidermal

30 accc-cancer.org | January–February 2016 | OI (EGFR) T790M (kitepharma.com) KTE-C19 for the mutation-positive NSCLC, as detected by treatment of patients with refractory Continued Medicare an FDA-approved test, who have pro- diffuse large B cell lymphoma, primary Coverage for PancraGEN™ gressed on or after EGFR tyrosine kinase mediastinal B cell lymphoma, and trans- PDI, Inc. (pdi-inc.com) subsidiary, inhibitor (TKI) therapy. formed follicular lymphoma. Interpace Diagnostics, announced that Novitas Solutions, Inc., the Medicare • The FDA has approved Wellstat Thera- Approved Devices Administrative Contractor (MAC) for peutics’ (wellstattherapeutics.com) Interpace Diagnostics has updated ® Vistogard (uridine triacetate) for the • The FDA has approved EDAP’s (edap-tms. its local coverage determination ® emergency treatment of adults and com) Ablatherm Integrated Imaging (LCD) for PancraGEN test, which children who receive an overdose of the High-Intensity Focused Ultrasound utilizes the PathFinderTG® platform. cancer treatment fluorouracil or cape- (HIFU) for the ablation of prostate tissue. The original coverage issued on Nov. citabine, or who develop certain severe or The Ablatherm Integrated Imaging device 5, 2010, provided “Coverage with life-threatening toxicities within four days precisely targets the tumor through a Appropriateness Development,” which of receiving these cancer treatments. computer controlled rectal probe. Ultra- required the company to routinely sound waves destroy the prostate tissue present updated data to further Drugs in the News with no damage to the surrounding organs. validate the test’s effectiveness. This treatment option is effective, efficient The new policy no longer includes • ArQule, Inc. (arqule.com) announced and adaptable, with early success determi- this condition for coverage and was FDA orphan drug designation for ARQ 087 nation and minimal side effects. effective Dec. 31, 2015. in cholangiocarcinoma. ARQ 087 is a multi-kinase inhibitor designed to • The FDA cleared for marketing in the U.S. preferentially inhibit the fibroblast growth the DigniCap Cooling System (Dignitana receptor (FGFR) family. Inc., dignitana.se/eng/) a cooling cap to reduce hair loss (alopecia) in female breast Genetic Tests and Assays in • Daiichi Sankyo, Inc. (dsi.com) and cancer patients undergoing . the News Plexxikon, Inc., a member of the Daiichi The system is indicated to reduce the Sankyo Group, announced that the FDA frequency and severity of alopecia during • The FDA has approved Roche’s (roche. has granted breakthrough therapy chemotherapy in breast cancer patients in com) cobas® EGFR Mutation Test v2 for designation to its investigational oral which alopecia-inducing chemotherapeutic companion diagnostic use. The next- CSF-1R inhibitor (formerly agents and doses are used. It is a computer- generation test from Roche includes PLX3397) for the treatment of tenosyno- controlled system that circulates cooled expanded mutation coverage of EGFR gene vial giant cell tumor (TGCT) where surgical liquid to a head-worn cooling cap during in DNA derived from tumor tissue. The test removal of the tumor would be associated chemotherapy treatment. The cooling cap is can be used to select eligible NSCLC patients with potentially worsening functional covered by a second cap made from who harbor a T790M mutation, for treat- limitation or severe morbidity. neoprene, which holds the cooling cap in ment with Tagrisso™ () or for place and acts as an insulation cover to eligible NSCLC patients with exon 19 • The FDA has granted breakthrough prevent loss of cooling. deletions or L858R mutations for treat- therapy designation to Kite Pharma’s ment with Tarceva® ().

OI | January–February 2016 | accc-cancer.org 31