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NICE rejects Pfizer’s ALL drug Besponsa - PharmaTimes, Pricing, reimbursement and access - Besponsa, NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE, Inotuzumab Ozogamicin (Besponsa) - An Antibody-Drug , Live Departure Boards - National Rail Enquiries, Find Information About BLINCYTO® (blinatumomab), Women's Army Corps - Wikipedia, Specialty Pipeline Monthly Update - Prime Therapeutics, New Drug Notices | Clinical Drug Information.
The National Institute for Health and Care Excellence has today published draft guidance not recommending Pfizer’s Besponsa to treat some patients with leukaemia on the NHS in England and Wales.The drug is being appraised by the Institute for treating adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).Besponsa (inotuzumab) is an antibody drug conjugate which is comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on around 90 percent of B-cell malignancies, linked to a cytotoxic agent.When the drug binds to CD22 on malignant B-cells it is taken into the cell, where the cytotoxic agent calicheamicin is released to destroy it.Data from the INO-VATE trial, which compared the drug to standard of care chemotherapy in 326 adult patients with relapsed or refractory CD22-positive ALL, and showed that the therapy more than doubled complete remission rates.However, in draft guidelines, NICE says evidence from clinical trials showed no survival benefit from Besponsa compared to current treatment, but more people who were treated with the drug were able to subsequently have a stem cell transplant and go into remission than those on standard care.Because of the “highly uncertain” survival benefits, the incremental cost effectiveness ratio (ICER) was over £100,000 per QALY for Besponsa, which is substantially higher than the range considered cost effective for routine use in the NHS.ALL is an aggressive type of leukaemia with high unmet need and a poor prognosis. The current standard treatment is intensive, long-term chemotherapy, but currently only 10 percent of adults with ALL who relapse after first-line therapy survive five years or more.It is estimated that 117 patients would be eligible for treatment with the drug in its first year if it were recommended for routine use.In a statement, David Montgomery, Oncology Medical Director of Pfizer UK, said: “Whilst NICE, in its initial assessment of inotuzumab ozogamicin, has acknowledged the benefit of this medicine for people with this aggressive  leukaemia, the draft decision is disappointing and yet again we are concerned for patients who so urgently need new treatment options. We remain focused on finding a solution so that eligible patients can access this medicine and we will work closely with NICE as the technology appraisal for inotuzumab ozogamicin progresses.”. Besponsa (inotuzumab) is an antibody drug conjugate which is comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on around 90 percent of B-cell malignancies, linked to a cytotoxic agent.. Second time lucky for Besponsa UK reimbursement bid. 09-08-2018. Following an appeal from New York’s Pfizer, the UK’s health technology assessor has decided to offer….
National Institute for Health and Care Excellence Final scope for the appraisal of inotuzumab ozogamicin for treating relapsed or refractory B- cell acute lymphoblastic leukaemia [ID893]. The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.. Warrington Central [WAC] Cycle hire availability Yes Cycle parking Yes. BLINCYTO ® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable traces of cancer after chemotherapy.. The Women's Army Corps (WAC) was the women's branch of the United States Army. It was created as an auxiliary unit, the Women's Army Auxiliary Corps (WAAC) on 15 May 1942 by Public Law 554, and converted to an active duty status in the Army of the United States as the WAC on 1 July 1943.. Mavyret’s WAC is $26,400 per treatment course for most patients, which is lower than other available treatment courses such as Gilead’s Sovaldi and Harvoni. 4 Besponsa ™ (inotuzumab ozogamicin): The FDA approved Pfizer’s Besponsa for the treatment of adults.
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