DrAlexUNC

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    • Genentech's Avastin: An Undeserving Target for Politicians and the Media [view article]
      Pharma - What is your point? Do you have a true understanding of the data, or do you rely on media blurbs to get your facts. If you understand the nature of the treatment of metastatic breast cancer, you would understand that PFS is a very viable endpoint. Never has a drug added 5.5 months on to the PFS endpoint vs. standard of care. The 2nd point is that in today's environment, women can receive multiple lines of therapy post progression. This hinders being able to capture OS data. In fact ECOG, when designing the trial took this point into account, and designed the trial based on historical endpoints in this population, and knowing that OS has not been the endpoint the FDA used in this population.

      The 20% side effect increase associated with the addition of Avastin to paclitaxel was mostly from hypertension - of which only 1 patient had to be withdrawn due to uncontrolled hypertension, neuropathy which is associated with cumulative dose of paclitaxel - the Avastin containing arm averaged 4 more cycles of therapy than the control arm, thus allowing more drug to accumulate, and 3rd, fatigue, which is also associated with more cycles of therapy. Compare the 20% increase in AEs to the earlier approved Ixabepilone (approved on TTP) and it's increased rates of toxicity which included a 70% increase in neutropenia and a 50% increase in neuropathy.

      The deaths in any study are a tragedy, and should not be discounted, but historically, in the MBC trials, you expect between a 1% and 3% death rate. This trial had a 2% death rate.

      To answer the question of why it costs $110,000 instead of $55,000 -
      for the patient, the maximum one would have to pay to get Avastin is $55,000/yr, based on the cap plan that Genentech instituted last year.


      Mar 27 09:47 AM
    • Genentech's Avastin: An Undeserving Target for Politicians and the Media [view article]
      The comments above are very off-base. First - please give the example of where Avastin in combination with "more advanced chemotherapy did not show any benefits to patients." Quite wrong. The only trials where avastin has not shown efficacy has been in the Pancreatic population. Those trials were stopped. The results of the large adjuvant CRC trials are expected to show prolonged survival and those results are expected late 2008/early 2009.

      The breast approval was controversial in some eyes, but not in the eyes of the majority of the patients and oncologists already using Avastin for prolonged patient benefits. By the way, the "independent scientific review committee" that you tout, is an extension of the FDA, and was comprised that day of 3 temporary voting members that were needed to fill the quorum of 9 voting members. The original vote of 5-4 against was reported to have privately been changed to a 6-3 vote for approval as one of the members of the temporary panel - an oncologist from MD Anderson - and a patient advocate changed their votes. The vote for approval from the practicing clinicians was 5-1 in favor of approval.

      The FDA has been using antiquated methods of looking at data to base how the new biologics work against cancer cells. Avastin alone has very little anti-tumor effect; but in combination with standard chemotherapy, it's mechanism of action allows for greater targeting of cancer cells and thus increased response, increased PFS, increased OS in some tumors, and better QOL. Does it have side effects - yes. But to those people who have benefited from Avastin therapy, those risks are worth the benefit.

      One last point, the European Community approved Avastin for Breast Cancer Months before the FDA approved Avastin's use for breast cancer - based on the same data which was presented before the FDA's ODAC panel.       Mar 26 09:51 AM
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