Nov 14, 20 another cancer drug approval, another nosebleedlevel price. Food and drug administration fda has approved imbruvica ibrutinib capsules as the first therapy indicated specifically for patients with waldenstroms macroglobulinemia wm, 1 a rare, indolent type of bcell lymphoma. Imbruvica is a kinase inhibitor indicated for the treatment of patients with. Chronic graft versus host disease cgvhd after failure of one or more lines of systemic therapy. Pharmacyclics receives fda approval for imbruvica in. Fda for the firstline treatment of chronic lymphocytic leukemia approval based on data from the phase 3 resonate2 trial showing an 84% reduction in. Member has received at least one prior therapy for mcl. Fda expands the use of ibrutinib to include combination. The chemical name of the ibrutinib is 1 3r34amino34phenoxyphenyl1h.
Us fda approves new imbruvicaibrutinib formulation. Nov, 20 imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma mcl who have received at least one prior therapy. In february 2014, imbruvica received accelerated approval to. Fda approval history for imbruvica ibrutinib used to treat mantle cell lymphoma. This is the first chemotherapyfree, anticd20 combination regimen approved for cllsll. European commission approves imbruvicatm in two forms of. General information about the safe and effective use of imbruvica medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. The latest fda approval expands the use of imbruvica, which can already be administered as a single agent or in combination with bendamustine and rituximab br for adult cllsll patients. Imbruvica is available as capsules 140 mg and tablets 140, 280, 420 and 560 mg. More information on the fdas approval of ibrutinib is available at the agencys web site. The new formulations are now commercially available, and the original 140 mg capsule will no longer be available after may 15, 2018.
The study population in the trial leading to approval received treatment with a median of three prior therapies. Abbvies imbruvica and rituxan combo snags fda approval. Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma mcl. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. Jan 20, 2017 this approval of imbruvica represents a welcome new oral option for the mzl community and is the first approved therapy for these patients, she said. Prescribed dose of imbruvica does not exceed 560 mg per day.
Horsham, pa, january 29, 2015 janssen biotech, inc. The fdas approval of imbruvica in chronic graftversushostdisease after failure of one or more lines of systemic therapy addresses an area of high unmet medical need for patients and marks the. Imbruvica is a kinase inhibitor indicated for the treatment of adult patients with. Pharmacyclics for the treatment of patients with wm. The approval of imbruvica provides a new, oncedaily oral therapy option for physicians. Aug 04, 2017 the fdas approval of imbruvica in chronic graftversushostdisease after failure of one or more lines of systemic therapy addresses an area of high unmet medical need for patients and marks the first approved use for the therapy outside of blood cancers, lori styles, md, senior medical director and gvhd program clinical lead at pharmacyclics, an abbvie company, said in a press release. Chronic lymphocytic leukemia cll, the most common type of leukemia in adults, is a cancer of bcell lymphocytes. New fda approval for the expanded use of imbruvica. Fda drug approval process infographic horizontal fda. Abbv, a global biopharmaceutical company, today announced the u. Fda approves imbruvica for expanded cll indication by estel grace masangkay the u. In clinical studies, some people responded to this medicine, but further studies are needed. A lucky drug made pharmacyclics robert duggan a billionaire. Ibrutinib, sold under the brand name imbruvica among others, is a small molecule drug that.
Chronic lymphocytic leukemia, follicular lymphoma gazyva obinutuzumab is a cd20directed cytolytic antibody indicated for the combination treatment of patients with chronic lymphocytic leukemia and follicular. Current indication based on favorable overall response rate. Jan 19, 2017 the fda approval of imbruvica for relapsedrefractory marginal zone lymphoma is significant, and we are proud of the culmination of this extensive clinical research program, representing the first approved treatment specifically for patients with this rare type of nonhodgkins lymphoma, said darrin beaupre, m. Brutons tyrosine kinase btk is a protein found in your b cells. Continued approval for this indication may be contingent upon verification and description of. In patients with mild impairment, reduce imbruvica dose 2. The expanded label marks the ninth fda approval for imbruvica since 20. You can save articles, manage email alerts, and easy revisit frequent searches. February 16, 2018 the fda approved pharmacyclics imbruvica ibrutinib tablets, which shares the same indications as imbruvica capsules. Highresolution, printable pdf of the drug approval process infographic pdf 2. Mantle cell lymphoma mcl who have received at least one prior therapy 1. Prior authorization approval criteria fallon health.
It is used in adults who have received at least one other cd20targeted therapy. Oct 17, 2014 european commission approves imbruvica tm in two forms of blood cancer firstinclass btk inhibitor for complex orphan diseases cll and mcl. Fda approves ibrutinib imbruvica in combination with. Imbruvica is a oncedaily, firstinclass brutons tyrosine kinase btk inhibitor that is administered orally, and is jointly developed and commercialized. In february 2014, the fda granted accelerated approval to imbruvica for use in patients with previously treated chronic lymphocytic leukemia cll, and then in july 2014, expanded its use to. Jan 29, 2015 the fda initially granted imbruvica accelerated approval in november 20 for use in patients with mantle cell lymphoma who received one prior therapy. Food and drug administration fda finally approved imbruvica ibrutinib as a firstline treatment for patients with. Fda oks ibrutinib imbruvica for mantle cell lymphoma medscape nov, 20.
For the treatment of adult patients with mantle cell lymphoma mcl who have received at least one prior therapy o accelerated approval was granted for this indication based on overall response rate. Leukemia drug imbruvica snagged another approval from the u. Mar 04, 2016 accelerated approval was granted for the mcl indication based on overall response rate. The firstinclass btk inhibitor imbruvica ibrutinib was approved by the fda for the treatment of patients with cll in february 2014.
Food and drug administration announced that it has approved an indication expansion for janssen biotechs and pharmacyclics imbruvica ibrutinib. The fda approval of imbruvica for chronic lymphocytic leukemia was. Beerse, belgium, october 17, 2014 prnewswire janssencilag international nv janssen announced today that the european commission has approved imbruvica ibrutinib capsules, a firstinclass, oncedaily, oral brutons tyrosine kinase btk. Imbruvica ibrutinib and risk of hepatitis b reactivation.
Another cancer drug approval, another nosebleedlevel price. The results of this trial led to the accelerated fda approval of ibrutinib for relapsedrefractory patients with cll. Imbruvica first received fda approval in wm as a monotherapy in january 2015 via the breakthrough therapy designation pathway, making it the first fdaapproved therapy for the disease. The fda is also approving new labeling to reflect that imbruvicas clinical benefit in treating cll has been verified. Imbruvica as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia cll see section 5. In a history making moment for wm patients, the iwmf is pleased to announce that imbruvica ibrutinib has just received fda approval specifically for the treatment of wm, thus becoming the first drug therapy to achieve this designation. Please see the full prescribing information for indications, dosage and usage. Development history and fda approval process for imbruvica. Fda approves imbruvica ibrutinib as first treatment. Aug 04, 2014 fda approves imbruvica for expanded cll indication by estel grace masangkay the u. Imbruvica was approved to treat mantle cell and marginal lymphomas by the us food and drug administration fda on an accelerated basis. Mantle cell lymphoma mcl who have received at least one prior therapy chronic lymphocytic leukemia cll or small lymphocytic. Prior authorization approval criteria imbruvica ibrutinib generic name. The fda s approval of ibrutinib for wm was based on a phase 2 multicenter study of 63 patients with previously treated wm.
Accelerated approval was granted for the mcl indication based on overall response rate. Fda approves imbruvica ibrutinib for the treatment of. Apr 16, 2014 second acts in the biotech business are hard. For medical information inquiries about imbruvica or to report a possible adverse event or product quality complaint, please contact pharmacyclics medical information by using one of the following two methods. Hcp information for oncedaily imbruvica ibrutinib hcp. The fdas approval of the combination treatment has added a new option for many wm patients, he said. The speed at which we were able to bring imbruvica to this point epitomizes the sense of urgency that drives oncology drug developers to bring important new medicines to patients in need, said craig tendler, m. Fda approves imbruvica ibrutinib for the treatment. This product information was approved at the time this auspar was published. Mantle cell lymphomain adults who have received at least one other treatment. It sends signals that help b cells stay alive and multiply. The regulatory agency gave the greenlight for imbruvica combined with gazyva for adult patients with previously untreated chronic lymphocytic leukemiasmall lymphocytic lymphoma.
His track record for drug development is hardly convincing. Ibrutinib became the first drug to receive approval for the treatment of patients with wm. Imbruvica is an oral oncedaily therapy that works to inhibit brutons tyrosine kinase btk, a signaling. Ibrutinib imbruvica is the only national comprehensive cancer network nccn category 1 preferred. Imbruvica is a kinase inhibitor indicated for the treatment of. Fda approved indications imbruvica is indicated for the treatment of. Fda approves imbruvica ibrutinib for firstline treatment of chronic lymphocytic leukemia approval based on phase 3 resonate2 trial showing imbruvica significantly improved. Fda approves imbruvica as first therapy for chronic graft. Jan 29, 2015 approval represents fourth indication for imbruvica in the u. Directly or indirectly, all parties to healthcare benefits influence policy and demand satisfaction of their interests.
Table 1 risk benefit assessment of ibrutinib in patients with. Fda gives greenlight to janssen and abbvies imbruvica for the 10th time. Do not use imbruvica for a condition for which it was not prescribed. Product information for auspar imbruvica janssencilag pty ltd pm20140278014 final 2 february 2016. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. Fda approves imbruvica plus rituximab for rare blood. Spending to bring a single cancer drug to market and revenues after approval. Treon was the lead investigator of the phase ii trial that served as the basis for imbruvicas 2015 approval for wm. Imbruvica, shown to be a welltolerated agent, has demonstrated a 95 percent response rate and deep remissions in these patients. See 17 for patient counseling information and fda approved patient labeling. The fda initially granted imbruvica accelerated approval in november 20 for use in patients with mantle cell lymphoma who received one prior therapy. Imbruvica ibrutinib is an oral brutons tyrosine kinase btk inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, waldenstroms macroglobulinemia, small lymphocytic lymphoma, marginal zone lymphoma, and chronic graft versus host disease. Apr 23, 2020 imbruvica is a kinase inhibitor indicated for the treatment of adult patients with. Dailymed imbruvica ibrutinib capsule imbruvica ibrutinib.
On february 16, 2018, imbruvica ibrutinib was approved by the us fda in multiple strengths as a 140, 280, 420, and 560 mg tablet. Us fda approves imbruvica in combo with obinutuzumab for. Imbruvica received a breakthrough therapy designation for this use. Imbruvica is being jointly developed and commercialized by pharmacyclics and janssen biotech, inc. This approval expands the use of ibrutinib, which can also be administered as a single agent or in combination with bendamustine and rituximab br for adult cllsll patients. Results from the randomized, multicenter, phase 3 resonate trial will act as confirmation for the accelerated approval. Imbruvica ibrutinib is an oral, oncedaily cllsll medicine that works differently than chemotherapy. New agent shows promise over imbruvica in treatment of cll. First and only fdaapproved treatment for wm patients. Imbruvica is specifically approved for the treatment of adult patients.
Approval represents fourth indication for imbruvica in the u. Accelerated approval was granted for the mcl and mzl indications based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a. Continued approval for this indication may be contingent. The fdas decision was based on results from the pcyc1121 phase 2 trial nct01980628, recently presented at the 58th annual american society of hematology ash meeting in december. Fda approves imbruvicarituxan combo for rare type of. The fda approval of imbruvica for chronic lymphocytic leukemia was based on an openlabel, multicenter trial of 48 previously treated patients. The 26month estimated rates of pfs and os were 75% and 83%, respectively. This helps stop cancerous b cells from surviving and multiplying.
Aug 02, 2017 the fda based the approval in part on results from the openlabel, multicenter, singlearm pcyc1129ca trial, designed to evaluate the efficacy and safety of 420 mg ibrutinib once daily for 42. Fda approves new imbruvica indication drug store news. Adult patients with mantle cell lymphoma mcl who have received at least one prior therapy o accelerated approval was granted. Fda approves imbruvica for certain marginal zone lymphoma. Accelerated approval was granted for this indication based on overall response rate. Imbruvica in patients with moderate or severe baseline hepatic impairment. Patients with positive hepatitis b serology who require imbruvica should be monitored and managed, according to local medical standards of care, to. Fda expands approval of imbruvica for rare blood cancer spec. Chronic lymphocytic leukemiaand small lymphocytic lymphomain adults. Table 2 drugs that have fda approval for mcl that has been previously treated. On january 29, 2015, the fda approved a new indication for ibrutinib imbruvica. Fda expands approved use of imbruvica for cll rxlist. This prior approval supplemental new drug application proposes the. Imbruvica is medically necessary when one of the following criteria are met.
The fda approval of imbruvica for relapsedrefractory marginal zone lymphoma is significant, and we are proud of the culmination of this extensive. If patients have positive hepatitis b serology, consultation with a liver disease expert is recommended before starting treatment with imbruvica. Imbruvica was one of the first medicines to receive u. You may report side effects to fda at 1800 fda 1088. Fda approval via the new breakthrough therapy designation pathway. Ibrutinibs approval history and its use as frontline therapy for cll. The agency approved imbruvica for patients with waldenstroms macroglobulinemia wm, a rare form of cancer that begins in the bodys immune system. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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