South Korean drug makers have seen several high-profile setbacks in recent months. What does this mean for overseas… https://t.co/HGl2jUJ7qw
Zytiga, the Lockerbie Bomber, and Access to Drugs for Advanced Prostate Cancers
The death of the Lockerbie bomber, Abdelbaset Ali Mohmed al-Megrahi, from metastatic prostate cancer, has thrust Johnson & Johnson's prostate cancer drug Zytiga (abiraterone acetate) into the spotlight. In August 2009, Al- Megrahi, diagnosed with metastatic prostate cancer and thought only to have a few months to live, was released from Scotland on compassionate grounds, only to live out more than two years of life in Libya. The extra lease on life has been attributed to treatment with Zytiga, placing the drug in a rather precarious position and undoubtedly causing J&J to wonder if this news should be celebrated or ignored.
How can a prognosis be so far off? It's part and parcel of cancer treatment. As much as technology has advanced and personalised therapy has become mainstream, how a therapy will affect each individual patient is still often a shot in the dark. Uncertainty prevails.
Al-Megrahi's situation harkens back to the FDA's revocation of Avastin's metastatic breast cancer label in the US based on data which showed that it did not improve overall survival and that, ultimately, the risks outweighed the benefits. While the agency was making the tough decision they held a two-day public hearing, during which many women presented personal anecdotes arguing that Avastin had saved their lives. How could the government revoke approval for a drug that is keeping me alive, the sentiment went? But how do you account for all those for whom the treatment doesn't provide any added benefit, and sometimes results in harsh, and quality of life lowering, side effects? These questions have plagued regulators and payors and are at the heart of many governments' healthcare policies.
The United Kingdom's NICE is currently grappling with this debate vis a vis Zytiga. NICE initially rejected the drug and the Al-Megrahi case acted as lightening rod for intense criticism surrounding NICE's decision. However, just days before Al-Megrahi's death, NICE made a u-turn and has now recommended the drug after the manufacturer provided an undisclosed price discount through a revised patient access scheme, quieting dissenters, at least for the time being.
Zytiga had less controversial developments keeping it in the public eye. ASCO has published approximately 4500 abstracts online which will be presented next week at its annual meeting. A Zytiga study was among the five studies, which ASCO chose to highlight from the milieu of abstracts. The Phase II study demonstrated that pre-surgical treatment with Zytiga in localized, high-risk prostate cancer, eliminated, or virtually eliminated cancer in 58 or one-third of the treated men. Clearly these are encouraging results. And yet, success won't be certain until more mature study results, such as overall survival data, comes to fruition. But fortunately for those familiar with the whims of cancer treatments and drugs, uncertainty is nothing new.
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