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Health Tree for Multiple Myeloma has recently posted several articles regarding Johnson & Johnson/Janssen’s bi-specific antibody teclistamab (CD3xBCMA) (see this article and this article for examples). There has been a groundswell of support for this product, now brand named Tecvayli, following updated clinical results at recent hematology conferences.
The European Medicines Agency (EMA) announced on July 22, 2022, that it has recommended a conditional marketing authorization to the European Commission (EC). EMA’s press release states:
“A range of new medicines for the treatment of multiple myeloma have been developed and approved in recent years, leading to a steady overall improvement in patient survival. However, for patients who have already been treated with three major classes of drugs (immunomodulatory agents, proteasome inhibitors and monoclonal antibodies) and no longer respond to these drugs, the outlook is still bleak. Therefore, new medicines are needed for these patients.”
They go on to explain what the conditional authorization means and what Janssen needs to do secure full approval in the future.
“Tecvayli is recommended for a conditional marketing authorization, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need. This type of approval allows the Agency to recommend a medicine for marketing authorization with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.”
“In order to better characterize the safety and effectiveness of the medicine, the company will have to submit data from a randomized phase 3 confirmatory study comparing the efficacy of teclistamab in combination with daratumumab SC with the treatment regimen daratumumab SC, pomalidomide, and dexamethasone (DPd) or daratumumab SC, bortezomib, and dexamethasone (DVd) in adults with relapsed or refractory multiple myeloma. The company is also required to submit the final results of the pivotal study.”
This is great news for our fellow European myeloma patients to provide them with early access. As a matter of personal opinion, I am convinced that US FDA will soon (in a matter of a few months) follow suit.
Health Tree for Multiple Myeloma has recently posted several articles regarding Johnson & Johnson/Janssen’s bi-specific antibody teclistamab (CD3xBCMA) (see this article and this article for examples). There has been a groundswell of support for this product, now brand named Tecvayli, following updated clinical results at recent hematology conferences.
The European Medicines Agency (EMA) announced on July 22, 2022, that it has recommended a conditional marketing authorization to the European Commission (EC). EMA’s press release states:
“A range of new medicines for the treatment of multiple myeloma have been developed and approved in recent years, leading to a steady overall improvement in patient survival. However, for patients who have already been treated with three major classes of drugs (immunomodulatory agents, proteasome inhibitors and monoclonal antibodies) and no longer respond to these drugs, the outlook is still bleak. Therefore, new medicines are needed for these patients.”
They go on to explain what the conditional authorization means and what Janssen needs to do secure full approval in the future.
“Tecvayli is recommended for a conditional marketing authorization, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need. This type of approval allows the Agency to recommend a medicine for marketing authorization with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.”
“In order to better characterize the safety and effectiveness of the medicine, the company will have to submit data from a randomized phase 3 confirmatory study comparing the efficacy of teclistamab in combination with daratumumab SC with the treatment regimen daratumumab SC, pomalidomide, and dexamethasone (DPd) or daratumumab SC, bortezomib, and dexamethasone (DVd) in adults with relapsed or refractory multiple myeloma. The company is also required to submit the final results of the pivotal study.”
This is great news for our fellow European myeloma patients to provide them with early access. As a matter of personal opinion, I am convinced that US FDA will soon (in a matter of a few months) follow suit.
about the author
Paul Kleutghen
I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and two grandsons who are the ‘lights of our lives’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. I am a firm believer that staying mentally active, physically fit, compliant to our treatment regimen and taking an active interest in our disease are keys to successful treatment outcomes.
