Replies to implications of the FDA’s decision to grant accelerated approval to treatment for patients whose cancers have a specific genetic biomarker
Response 1: Ariella Jaffe
The implications of the FDA’s decision to grant accelerated approval to treatment for patients whose cancers have a specific genetic biomarker rather than the location in the body where the tumor originated for both diagnostic companies and drug developers are still playing out across both industries. Overall, this change will shift both industries towards the direction of personalized medicine, where patients’ genetic information is used to make decisions on how to treat their disease (Yan & Zhang, 2018).
For diagnostic companies, this decision means that diagnostics are even more important for drug developers than ever because diagnostic test holds the key to who these drugs will be prescribed to. This means that an increase in funding from drug developers may be seen to foster relationships and work together on biomarker detection testing to support patient discovery (Fridlyand et. al., 2013). Additionally, this change brings the implication that diagnostic companies will be put under increased pressure to rigorously validate their biomarker assays (Boyiadzis et. al., 2018); this is because in the case of these non-tumor location specific drugs, allocation and use is based on the results of biomarker diagnostic tests, making their validity even more crucial than before.
For drug developers, this decision primary means that the way these drugs have been developed in the past needs to change. More specifically, this means that drug developers are incentivized to look at therapeutic efficacy of their current drugs as well as those in development against multiple tumor types (Boyiadzis et. al., 2018). Additionally, this change means that drug developers can go from development to FDA approval faster than was possible before. Some say that this accelerated approval could weaken the extensive clinical data requirements and verification of those requirements that the FDA requires for approval (Mullard, 2021). An example of this can be seen with Roche’s cancer drug Atezolizumab, where the drug was approved by the FDA even though the data from the IMpassion130 clinical trial showed that the drug did not increase survival of participants at the benchmark level they sought out to (Mullard, 2021).
Response 2: Alverta Joseph Mikhael
Biomarkers are crucial tools for drug discovery, development and approval of new medicines. They can contribute to a quicker development of safer and more effective medicines (Gromova, et al., 2020). Over 20% of drugs approved by FDA between 2014 and 2018 and around 42% in 2018 alone belong to “personalized medicines” (Gromova, et al., 2020). The way biomarkers contribute to the development of medicines is by properly identifying the target population which has the highest potential of a benefit and the lowest risk to develop unwanted adverse reactions, this has a positive impact on healthcare’s spending and even provides a good reason for reimbursement agreements, also biomarkers help in selecting the most favorable drug candidates, which significantly reduces costs and the probability of failure at later stages (Gromova, et al., 2020). This decision will certainly have a big impact and its implications are listed in the following points.
First, the implications of this decision for diagnostic companies will be tremendous, as the biomarker’s development will help facilitate the whole process, and eventually improve cancer patient care through the application of “Precision Medicine” (Goossens et al., 2015). However the biomarker’s development may be associated with additional testing requirements or extended clinical trials, thus a possible increase in development costs (Gromova, et al., 2020). which could be a bit overwhelming for these diagnostic companies.
Second, the implications of this decision for drug developers, utilization of biomarkers has a huge potential in facilitating the discovery of new drugs and its development (Gromova, et al., 2020). Scot W. Ebbinghaus, MD, vice president for clinical research at Merck Research Laboratories, had stated that the collaborative efforts to advance biomarker research have provided a new treatment options for patients with cancer (Healio, 2020). For certain pharmacotherapeutic groups, approvals with biomarkers are even more common than without them, and there has been a slight increase in the acceptance of biomarkers in recent years, even though that growth is not continuous (Gromova, et al., 2020).
To summarize, the use of biomarkers in a suitable way has the potential to make drug development more sustainable, improve quality and safety of a drug and accelerate approval process significantly, however for diagnostic companies there might be increase in development costs for the additional testing requirements for its validation (Gromova, et al., 2020). Nevertheless the future of biomarkers is looking bright, by facilitating the combination of therapeutics with diagnostics they will definitely be playing a big role in the future development of personalized medicine (Kamel & Al-Amodi, 2016).
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