FDA Approval For a New Glioblastoma Treatment

Title:  FDA Approval for Avastin - a new glioblastoma treatment
Grantee: Genentech

Regardless of where in the body they grow, all solid tumors need oxygen and nutrients to survive.  This idea is the basis behind Avastin, a tumor-fighting drug that is being used to treat a variety of human cancers.  Avastin blocks the growth of new blood vessels within tumors and thereby starves the tumors of the oxygen and nutrients they critically need to grow.  Even though Avastin could work to fight brain tumors, clinical trials for brain cancer are considered to be too risky for many pharmaceutical companies.  Moreover, they are expensive and limited to small numbers of patients compared to other, much more prevalent types of cancer.

To combat this problem, ABC2 in 2003 initiated a revolutionary partnership with the biotechnology giant Genentech.  ABC2’s goal in this partnership was to move Avastin rapidly into clinical testing for glioblastoma—by directly funding the trials themselves.  This unprecedented “buying down” of Genentech’s financial risk was a marked success: after demonstrating positive results in two clinical trials, Avastin received accelerated FDA approval in 2009 for the treatment of recurrent glioblastoma, becoming the first drug approved for glioblastoma in over a decade.

When a drug receives accelerated approval from the FDA, however, it undergoes additional testing to confirm that it really works.  Clinical trials of Avastin in combination with a wide variety of available therapies are ongoing in both newly diagnosed and recurrent glioblastoma.

Since Avastin’s approval, ABC2 has remained actively engaged with its journey toward the clinic.  When late-stage trials to confirm the drug’s safety and effectiveness produced conflicting results, ABC2 stepped in to advocate for FDA review of the full results from the trials in question.  This ongoing review will coordinate and harmonize the data and thus provide the best possible information as the FDA considers Avastin’s final approval.

ABC2 is committed to continuing to provide a leadership voice encouraging the expedited and rigorous evaluation of Avastin in glioblastoma.