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ON CANCER, |
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Why most cancer treatments don’t save lives. Cancer cells slightly modified normal
cells—only about 6 genes are typically involved. Very few drugs can distinguish between cancer
and normal cells. Thus if they have the
ability to destroy cancer cells, they will also destroy normal cells. Instead of targeting the cancer directly with
a lethal chemical and destroying it, most cancer treatment drugs (those which
average under a year extension of life) target a process which affects the
ability of cells to reproduce, grow in the body, absorb glycogen etc. The cancer drug doesn’t just affect the
cancer cells, but most of the cells in the body. However, one cannot shut down this process;
often just reduce the rate at which the process occurs. These processes are essential for normal
cells as well as the cancerous cells. A
drug which diminishes the product of capillaries affects the health of all
tissues since the body is at a slow pace replace as need old and damage capillaries. Cancer to grow needs as the tissue
expands
the nutrients supplied by the blood through the capillaries. The information for the news release below is provided by
Hoffmann-La Roche, and like all such releases there is a positive bias. Vemufafenib affects the BRAF gene which codes
for the B-Raf protein, which is involve in signaling in the cell growth
process. The overall survival was 13.3 months which is
3.4 months better than the standard treatment with dacarbazine. Missing is the survival for those untreated
which would be around 8 months (guestimate based on the fact that those with
this type of melanoma; however, drug tests are always performed on the atypical
group of younger patients whose condition is less severe than the
average.) When there is proper review, the results are
less than those in industry generated journal articles. Cochrane Review, found in their meta study of
metastatic colorectal cancer survival was increased by 3.7 months. |
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European Medicines Agency recommends approval of
first-in-class treatment for metastatic or unresectable melanoma http://www.fiercepharma.com/press_releases/european-medicines-agency-recommends-approval-first-class-treatment-metasta?utm_medium=nl&utm_source=inter European Medicines
Agency recommends approval of
first-in-class treatment for metastatic or unresectable melanoma The European Medicines
Agency's Committee for Medicinal Products
for Human Use (CHMP) has recommended the granting of a marketing authorisation
for a novel protein-kinase inhibitor to treat patients suffering from
metastatic or unresectable melanoma with BRAF V600 mutations. Melanoma is the sixth
most common malignancy in men and the
seventh most common malignancy in women. In Europe, doctors diagnose almost
60,000 new cases of melanoma per year. Approximately 8,300 men and 7,600 women
die from this type of cancer every year. When detected and treated early,
patients with localised melanoma have an
excellent prognosis, with a survival rate of more than 90%. However, for
patients with unresectable or metastatic melanoma, the prognosis remains poor:
it is estimated that only 25.5% of patients diagnosed with this type of disease
are still alive one year after first diagnosis; five years after the first
diagnosis, less than 15% of patients are still alive. There is a high unmet medical need for alternative treatments for
metastatic melanoma that improve survival of patients. In the pivotal clinical
trial, Zelboraf (vemurafenib), the new protein-kinase inhibitor, was compared
to the standard first-line treatment of dacarbazine. The medicine was shown to
improve progression-free survival (PFS) by about 4 months (5.3 months for
vemurafenib compared to 1.6 months for dacarbazine) and overall survival (OS)
by about 3 months (13.2 months for vemurafenib compared to 9.9 months for
dacarbazine) in patients who tested positive for BRAF V600 mutations. In its assessment,
the CHMP also looked at potential side effects
of Zelboraf. The Committee considered that although there was a risk of
secondary neoplasms, most notably squamous cell carcinoma of the skin (cuSCC),
the magnitude of the risk was likely to be low. The Committee also noted that
the applicant's risk-management plan for this medicine detailed adequate
risk-minimisation measures and the product information contained appropriate
information so that cuSCC can be managed in clinical practice, e.g. by routine
monitoring during treatment. Following review of
all available data, the Committee concluded
during its December 2011 meeting that the benefits of Zelboraf, particularly
the improvements seen in terms of PFS and OS of patients, outweigh its risks,
and recommended that a marketing authorisation should therefore be granted.
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