UK’s MHRA Allows Early Access to Roche Bladder Cancer Treatment
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will allow Roche’s atezolizumab to be used as part of an early access program for locally advanced or metastatic urothelial carcinoma.
In terms of why the new treatment won a positive Early Access to Medicine Scientific (EAMS) opinion, MHRA said: “Atezolizumab has been shown to slow the progression of cancer and increase patient survival in a condition where other treatments currently have poor results (about 20% of patients alive after 12 months). With regard to the medicine’s side effects, the most frequent were mild to moderate in severity and less frequent than with chemotherapy. Advanced cancer of the bladder and urinary system is a fatal condition, and currently few therapies are available with low efficacy.”
Background
In March 2014, MHRA announced it was launching EAMS to allow earlier access to potentially lifesaving medicines for patients with severe or life-threatening conditions.
For a product to qualify, it must be granted a promising innovative medicine (PIM) designation based on early (Phase I and/or II) clinical data and satisfy additional criteria including the severity of the condition the product is intended to treat and the level of improvement over previously authorized treatments.
Since EAMS approval is based on early clinical data, companies are required to provide MHRA with regular reports documenting adverse effects, and should notify the agency of changes to treatment protocols based on data gathered through the product's use.
The 10 expired EAMS opinions include those for:
- AbbVie and Genentech’s venetoclax (for chronic lymphocytic leukemia)
- Bristol-Myers Squibb’s nivolumab to treat a type of cancer of the lymph system, for kidney cancer, for two types of lung cancer and melanoma
- Merck’s pembrolizumab for lung cancerand melanoma
- AstraZeneca’s osimertinib (for lung cancer)
- Novartis' sacubitril/valsartan (for heart failure)
In addition to Monday’s positive opinion for atezolizumab, Merck’s pembrolizumab for non-small cell lung cancer is the only other current EAMS.
Between April 2014 and January 2017, MHRA has now received 40 applications for step I PIM designations and granted 27 of them, while only refusing seven (five are pending and one has been withdrawn).
And for the same period for EAMS step II applications, MHRA says it has received 14 applications, awarded 11 positive opinions, refused two and one is pending.