Takeda Pharmaceutical's top cancer prospect won a speedy FDA approval, wading into a crowded market for multiple myeloma treatments with hopes of duplicating the success of Velcade. The drug, ixazomib, is approved for relapsed and refractory multiple myeloma, a form of cancer that begins in the blood marrow. The nod comes just two months after the FDA accepted Takeda's application, reflecting the agency's increasing willingness to quickly approve new cancer treatments. Ixazomib, which Takeda plans to market as Ninlaro, is the third multiple myeloma drug approved this year, following Johnson & Johnson's Darzalex and Novartis' Farydak. Like Takeda's blockbuster-selling Velcade and Amgen's Kyprolis, ixazomib is a proteasome inhibitor, designed to kill tumors by cutting off the production of proteins they need to grow. But unlike those injected therapies, Takeda's new treatment is a pill, and the company believes ixazomib could reach blockbuster status by unseating some aging competitors in hematology. The drug has also showed promise in the related indication of systemic light-chain amyloidosis, which won it the FDA's coveted breakthrough-therapy designation. Ixazomib's approval clears it for use alongside Celgene's Revlimid and the corticosteroid dexamethasone in multiple myeloma patients who have already undergone first-line therapy. Takeda is working through four additional Phase III studies designed to widen ixazomib's indication, testing the drug in newly diagnosed multiple myeloma and amyloidosis.
So basically an oral Kyprolis. With Velcade going generic, oral kyprolis and a mAB with new JnJ drug that is more efficacious, how is Kyprolis going to hit the multi-billion dollar status to justify the acquisition?
KYPROLIS DOSING: Hydrate prior to and following administration.as needed. (2.1) Premedicate with dexamethasone prior to all Cycle 1 doses and if infusion reaction symptoms develop or reappear. (2.1, 2.2) Administer intravenously as a 10 minute infusion on two consecutive days each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). (2.1, 2.2) Kyprolis is administered at a starting dose of 20 mg/m2 /day in Cycle 1 on Days 1 and 2. If tolerated, the dose should be escalated to a target dose of 27 mg/m2 /day on Day 8 of Cycle 1. NINLARO DOSING Recommended starting dose of 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle. (2.1) Dose should be taken at least one hour before or at least two hours after food. (2.1) NINLARO IS WAY EASIER TO TAKE AND THE SAME MOA. KYPROLIS DOWN!!!
Takeda Pharmaceutical Co. lost a court ruling that could shave years off the time before generic-drug versions of its top-selling cancer drug Velcade hits the market. A patent on the medicine that expires in 2022 is invalid, U.S. District Judge Gregory Sleet concluded Thursday. He agreed with generic-drug makers who said the patent for a formulation of the drug is “the inherent result of an obvious process.” The ruling means that a generic version of the medicine could enter the market when another patent expires in May 2017. How will Kyprolis make $2-$4B to justify the cost?
Here are the top 5 things to know about Ninlaro: Manufactured by Takeda Pharmaceuticals, Ninlaro will be available in early December. Ninlaro is a unique multiple myeloma treatment, since it is available in pill form. “Ninlaro’s oral administration may help reduce the logistical burdens many multiple myeloma patients face with other therapies that require an infusion or injection,” Christophe Bianchi, MD, president of Takeda Oncology, told FormularyWatch. “We recognize there is a need for simple, safe and sustainable therapies for patients with multiple myeloma. We also want to help address the quality of life factors that impact patients every day." Each Ninlaro 28-day cycle of treatment is list priced at $8,670, similar to the monthly cost of Velcade. “Velcade has consistently been viewed by independent bodies – such as ASCO, Memorial Sloan Kettering Cancer Center and the NCCN – as a drug with great value. We aspire to continue this value proposition with Ninlaro,” according to a statement from Takeda Oncology provided toFormularyWatch. “While we are confident in the value Ninlaro brings, we have not priced the drug at a premium.” Takeda Pharmaceuticals submitted a New Drug Application for Ninlaro to FDA in July 2015, and in September, Ninlaro was granted Priority Review status with a PDUFA date of March 10, 2016. FDA’s approval of Ninlaro is based on results from the TOURMALINE-MM1 phase 3 clinical trial, the first double-blind, placebo-controlled trial with a proteasome inhibitor. The TOURMALINE program has enrolled approximately 3,000 patients in 40 countries. “We, as investigators of the TOURMALINE-MM1 trial, felt it was vital to conduct a comprehensive ‘real-world’ evaluation of this combination that included some of the most common patient types in the relapsed/refractory multiple myeloma setting, such as older patients, patients with moderate renal impairment, light chain disease, and high-risk cytogenetics,” Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center Institute, physician at Dana-Farber Cancer Institute, and investigator for TOURMALINE-MM1. “Further, we treated patients until disease progression to determine the sustainability of Ninlaro in treating their relapsed/refractory disease. The TOURMALINE-MM1 data demonstrate convincingly that oral NINLARO-based triplet treatment is effective at extending progression-free survival, over and above the clinical benefit seen with lenalidomide and dexamethasone, with a tolerable safety profile.”
Johnson & Johnson's Latest FDA Approval Could Spell Problems for Amgen Johnson & Johnson's newly approved multiple myeloma drug, Darzalex, is worth keeping an eye on for a number of reasons. http://www.fool.com/investing/general/2015/11/25/johnson-johnsons-latest-fda-approval-could-spell-p.aspx
Another Multiple Myeloma Drug comes to market! That's 3 drugs in one month! So tell me, how will kyprolis be a 3B+ drug? Can Bristol-Myers Squibb And AbbVie's Empliciti Become a Top Seller? The FDA's approval of Empliciti could reshape second-line multiple myeloma treatment
AbbVie Inc. (ABBV - Analyst Report) and its partner Bristol-Myers Squibb Company (BMY - Analyst Report) announced that the FDA has approved Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma patients who have received one to three prior therapies. This makes Empliciti the first and only immunostimulatory antibody to be approved for the treatment of multiple myeloma. FIRST IN CLASS BABY! Empliciti is also under review in the EU as a combination therapy for the treatment of multiple myeloma patients who have received one or more prior therapies. It has been granted accelerated assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Everyone in the industry knows Amgen can't compete in crowded therapeutic areas. They only can sell when they are the only game in town. Look at what happened to Enbrel. 4 year lead in RA and know deferring leadership to Abbvie.
