CognitrexCancerDigest

The U.S. Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib) for treating adults with chronic graft versus host disease (cGVHD) after failure of one or more treatments.   This is the first FDA-approved treatment for cGVHD.   cGVHD is a life-threatening condition that may develop in patients after they receive a hematopoietic stem cell transplantation (HSCT) to treat various blood and marrow cancers.   cGVHD develops as a result of cells from the transplant attacking the recipients own cells. It is estimated to occur in 30-70% of patients who receive HSCT.   “Patients with cGVHD who do not respond to other forms of therapy—typically corticosteroids to suppress their immune system—now have a treatment option specifically indicated to treat their condition,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Res...

The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML. “Idhifa is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.” AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the blood...

The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6. Back  in January , a tratsuzumab molecule developed by Indian drug firms Mylan and Biocon became the first biosimilar of Roche’s blockbuster anti-HER2 monoclonal antibody Herceptin to be accepted for review by the US Food and Drug Administration (FDA). And  last month an FDA committee voted unanimously in favour of its approval, paving the way for the first Herceptin biosimilar to arrive in the US. But while Mylan is looking to take a slice of a market which raked in  CHF 2.5bn ($2.6bn) for Roche last year , the firm may soon have to compete against a number of other competitors, including two more Herceptin biosimilars which were successfully submitted to the FDA for review this week: ABP980 and CT-P6. ABP 980 is one of four oncology biosimilars being co-developed following a $400m collaboration ink...

Bristol-Myers Squibb Company  (NYSE:BMY) and  Clovis Oncology, Inc. (Nasdaq:CLVS) announced the companies have entered into a clinical collaboration agreement to evaluate the combination of Bristol-Myers Squibb’s immunotherapy  Opdivo   and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor  Rubraca  in pivotal phase 3 clinical trials in: Advanced ovarian cancer : First-line maintenance treatment study to evaluate  Rubraca  +  Opdivo ,  Rubraca ,  Opdivo  and placebo in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube, or primary peritoneal cancer who have completed platinum-based chemotherapy. Advanced triple-negative breast cancers  (TNBC): First-line maintenance treatment study to evaluate  Rubraca  +  Opdivo ,  Rubraca ,  Opdivo  and chemotherapy in patients with stage IV or recurrent locally advanced inoperable TNBC associated with a homologo...

A highly anticipated clinical trial combining two immunotherapy drugs failed to delay tumor growth in patients with newly diagnosed lung cancer, sending AstraZeneca sharply lower Thursday. The negative results from the so-called MYSTIC study are a stinging setback to AstraZeneca’s ambition to leapfrog over its cancer immunotherapy rivals. Three years ago, AstraZeneca CEO Pascal Soriot rebuffed a $117 billion takeover offer from Pfizer, insisting the Anglo-Swedish drug maker’s pipeline would succeed on its own. On Thursday, AstraZeneca shares plunged 16 percent to $28.60 on investor fears that Soriot’s promise is coming up empty. In the preliminary MYSTIC clinical trial results, the combination of checkpoint inhibitor Imfinzi and the CTLA-4 inhibitor tremelimumab failed to slow disease progression compared to chemotherapy. The patients enrolled in the study were newly diagnosed with non-small cell lung cancer that expressed a protein known as PD-L1 on 25 percent or more of the...

To reach out to cancer patients irrespective of their location and help them get best treatment for the deadly disease, Navya Expert Opinion Service has commenced an online service where cancer patients can seek expert advice from oncologists at Tata Memorial Centre in Mumbai in a 24/7 environment within the confines of their homes.Gitika Srivastava, Founder of Navya, says,''This service, available at www.navya.care, allows patientsto upload their reports and get a response from world renowned experts within 24 hours.Once reports are received, patient advocates reach out to users to gather all relevant case information including preferences and constraints. The medical history along with evidence based treatment options are presented to a relevant expert using Navya's patented system. On receiving the expert's response, a report is created that answers all questions asked by the patient in language that is simple to understand.''''Reports are also sent ...

British pharmaceutical giant AstraZeneca and US peer Merck said Thursday they had agreed a multi-billion-dollar deal to jointly develop key cancer drugs. However, AstraZeneca shares tumbled 15 percent as investors fretted over disappointing trial results for its next-generation lung cancer treatment. Sentiment took another heavy blow on news that Astra's first-half sales were hurt by the loss of US patent protection on two blockbuster drugs. The Merck tie-up illustrates the growing prominence of oncology in the global pharmaceutical sector. "The strategic collaboration is expected to further increase the number of treatment options available to patients," Merck and Astra said in their joint statement.  Merck will pay AstraZeneca up to $8.5 billion (7.2 billion euros) under the deal struck to develop and commercialise the drugs. Central to the agreement is "a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca's L...