AstraZeneca will be resuming its cancer drug trials after the FDA put a temporary stop so as to investigate two durvalumab drug trials.
AstraZeneca was amidst two PD-L protein inhibitor drug trial test involving durvalumab when the FDA issued a temporary suspension.
The reason behind said suspensions were the series of unexpected side effects which included patient bleeding.
Said trial patients were taking part in two durvalumab studies which involved head and neck squamous cell carcinoma sufferers.
The United States Food and Drug Administration or the FDA put a temporary stop to the trials as the registered patients registered heavy blood losses.
As the trials were put on partial hold, it meant that although currently registered patients were still part of the study, new recruitments would be stopped.
AstraZeneca went to explain the bleeding and hemorrhages are not uncommon in such trials due to the nature of the study subject.
Head and neck cancers are known to develop in close proximity to major blood vessels. After further studies, it was determined that the durvalumab does not directly link to the bleedings.
Both the nature of the cancers and other therapy methods such as radiations and surgery could have led to the hemorrhages.
The Phase III trial studies involved were the KESTREL and the EAGLE. As any interested patient can enroll in the KESTREL study from any clinical study site, EAGLE will also begin recruitments soon.
According to a recent AstraZeneca statement, the studies have been cleared and will be reinitiated. No amendments have been added to the study protocols.
AstraZeneca’s KESTREL study will be testing the efficiency of durvalumab and tremelimumab. The two drugs will be compared to the Eli Lilly Erbitux plus chemotherapy.
Their effects will be compared to the cetuximab chemo as either a combination between the two or as the single drug in a durvalumab monotherapy.
The EAGLE study will be comparing the same durvalumab and tremelimumab effects but in relation to the standard care tactics selected by a physician.
According to AstraZeneca, enrollments in the two Phase III trials will be progressively resumed across both the national and global participating sites.
Durvalumab and tremelimumab are featured in more cancer trial studies. Besides the head and neck cancer studies, AstraZeneca is also testing their utility in relation to lung and bladder cancer types.
Whilst the head and neck study trials were put on temporary hold, the rest of the studies continued in their usual manner.
AstraZeneca will be relying quite heavily on the efficiency of the durvalumab and its own experimental tremelimumab medicines.
As they could potential lead to a longer patient survival period, they would also contribute to the treatment of several other cancer types and their tumors.
The company will also be gaining quite a profit if the drugs come to be approved and used in treatments.
AstraZeneca revealed that these drugs could potentially bring in an increasing $45 billion revenue company value by 2023.
The number would be also double as compared to the revenue value of $25 billion that the company registered in 2015.
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