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FDA Approves the New Blood Cancer Drug- Imbruvica
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The drug Imbruvica developed by Pharmacyclics and Johnson and Johnson to treat a rare type of blood cancer termed as Mantle cell Lymphoma is approved by Food and Drug Administration (FDA) on 13th November 2013.

The drug Imbruvica with its generic name Ibrutinib is designed to treat the recurrence of the Mantle cell lymphoma in patients who have been subjected to a therapy before. Mantle cell lymphoma is an atypical condition considered one among the non-Hodgkin’s lymphomas and is categorized under B cell lymphoma. Mantle cell lymphoma is associated with somatic cell mutation and is characterized by the hyper expression of the cell cycle gene called as cyclin D1 which in turn accelerates the unusual proliferation of the cancer cells. Since the disease is a result of somatic cell mutation it is not inheritable in nature. The survival of a patient with mantle cell lymphoma is calculated to be about 6 years in recent times. The possible locations where the cancer cells of mantle cell lymphoma can spread are identified as lymph nodes, spleen and bone marrow. The drug Imbruvica is designed to target and restrict the synthesis of a specific protein called Bruton’s Tyrosine Kinase, a key molecule supporting the growth and existence of B cells which turns out as cancerous cells in Mantle cell lymphoma.

Last year, Imbruvica was acknowledged by FDA as a breakthrough therapy for three different types of cancer which led to the much earlier approval of the drug this year prior to the stipulated time. Imbruvica grabbed FDA’s approval following the results of the clinical trials of the drug. The outcomes of the clinical trials are,

No. of patients tested: 111 (patients included in the study had recurrence of cancer even after a prior therapy).

Reduction in the condition observed: 49% out of 111 patients

Condition vanished in: 17% out of 111 patients.

Dosage: 4 capsules at a time once a day

Cost per capsule: $ 91

Side effects of the drug: low platelet counts, bleeding, susceptible to infections, fatigue and muscular pain, diarrhea, diminished white blood cell count and difficulty in breathing.

Other Approved Drugs against Mantle cell Lymphoma: Revlimid by Celgene, Velcade by Takeda and Rituxan by Genentech.

The approval of the drug Imbruvica by FDA had positive impact on the share values and stocks of the companies involved in the development of the drug.

At present Pharmacyclics and Johnson and Johnson are in the process of gaining approval of the drug Imbruvica for the treatment of chronic lymphocytic leukemia.

Reference
http://www.nytimes.com/2013/11/14/busine....html?_r=0
http://www.drugs.com/imbruvica.html
http://en.wikipedia.org/wiki/Mantle_cell_lymphoma
http://guardianlv.com/2013/11/fda-approv...-lymphoma/
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FDA Approves the New Blood Cancer Drug- Imbruvica00