SWITZERLAND – Roche has received approval from the U.S. Food and Drugs Administration for its Ventana MMR RxDx panel, a diagnostic test to help identify patients with solid tumors which could turn cancerous.
The test evaluates a panel of DNA mismatch repair (MMR) proteins in tumors to provide important treatment information to clinicians, the company said. When MMR is deficient, cells mutate which can lead to cancer.
Even as the Swiss drug maker celebrates this milestone, the World Health Organization has called on the company to ensure fair distribution of its arthritis drug used to treat COVID-19 patients as supplies of the drug run low due to rising cases driven by the more infectious Delta variant.
“While we welcome and acknowledge that Roche has announced measures to address the shortage, we call on the company to ensure equitable allocation of current stocks of this medicine for all countries, including low- and middle-income countries,” the WHO and health agency Unit aid said in a joint statement.
In a statement on Monday, Roche’s U.S. unit Genentech warned of a global shortage of tocilizumab, sold by Roche as Actemra and RoActemra, which will last at least for the next few weeks.
The latest wave of the pandemic has led to unprecedented demand, with orders well over 400% of pre-COVID levels over the last two weeks, it said.
The company has been working to fulfil the large volume of orders, by shipping medicine direct to hospitals and clinics in COVID-19 hotspots and collaborating with distributors and carriers to find logistics solutions, it said.
The company has also contracted manufacturers to transfer technologies and boost output last year before it was used for COVID-19 patients.
Still, Genentech has notified its customers that it has sold out of the drug in the United States in 200 milligram (mg) and 400 mg, and 80 mg supplies will run out by the end of the week.
New stock will arrive by the end of August, but if the pandemic continues at its current pace, there will be additional periods of disruption in the weeks ahead, it warned.
The squeeze comes after the U.S. regulator approved the drug for emergency use in hospitalized patients who need oxygen and the WHO also recommended it in June after promising clinical trial data.
WHO is working with Roche to get the drug to places where it is not yet in use as part of the Access to COVID-19 Tools Accelerator (ACT-A), its programme to fairly distribute COVID-19 vaccines, drugs and tests across the world.
The WHO has also issued a call for expression of interest to its prequalification programme to expand the number of quality-assured manufacturers of the drug to increase global supplies as well as calling for Roche to facilitate technology transfer and knowledge.
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