Medicare continues to support Avastin
Medicare will continue to support the drug Avastin following an announcement yesterday by a spokesman for the Centers for Medicare and Medicaid Services (CMS) - Don Mcleod who said the state insurance company would not stop paying for it.
The drug, which warrants around $8,000 a month for additional treatment on top of chemotherapy, remains unapproved by the Food and Drug Administration (FDA) governing body.
Reports today meanwhile emerged of the drug's classification being expanded. European regulatory bodies have allowed Metastatic Breast Cancer to be treated by Avastin in combination with another Roche/Genentech drug - Xeloda - outside of the USA.
The key report in question, follows a study - RIBBON-1 - which states that Avastin in combination with Xeloda improved survival from 5.7 months to 8.6 months (+50%).
“We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.” said Hal Barron, Chief Medical Officer, and MD of Genentech, who manufactures the drug for Roche yesterday.
The improve in survival of patients taking Avastin in combination with other chemotherapy is based on evidence which show that Avastin's anti-angiogenesis effects (halting the growth of blood cells in cancers) is extremely targeted in metastatic cancers including Breast - improving survival by up to 5.5 months.
However, following a report by Food and Drug Administration last year, the drug was considered insufficient for public use. A further four trials (E2100, AVADO, and RIBBON-1 for first-line metastatic breast cancer and AVF2119g for second-line treatment) had been observed.
The resulting FDA meetings observed that whilst the drug improved ORR (Overall Response Rate) - tumour assessments, x-rays, physical examinations etc. the patients themselves did not 'feel' like their livelihood was better.
In one particular trial for second line use of Avastin with Xeloda, patients actually felt worse after taking the drug leading the PFS to fall into negative.
The drug however remains particularly efficacious at tackling other forms of metastatic cancer, including lung, brain, kidney and colon cancers and will remain on the market FDA-approved - though will now need to be prescribed off-label to breast cancer patients.
Please contact the FDA for more information.
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