BMS Team Celebrates Accelerated FDA Approval for Multiple Myeloma
BMS

BMS Team Celebrates Accelerated FDA Approval for Multiple Myeloma

Bristol Myers Squibb shared on LinkedIn:

“The U.S. FDA granted accelerated approval to our treatment for certain patients with Multiple Myeloma, introducing a new class of treatment.

This milestone represents the continued evolution of our robust oncology portfolio with the potential to reshape what may be possible for patients living with this often recurring disease.

Today’s approval reflects the dedication of the patients, investigators and study teams who contributed to this work.”

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U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb’s First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

To which Michael Pourdehnad, Senior Vice President, Head of Early Clinical Development, Hematology/Oncology and Cell Therapy at Bristol Myers Squibb, added:

“This approval is an important milestone for multiple myeloma patients and another step forward for the field of targeted protein degradation (TPD).

What makes this moment especially meaningful is what it represents: years of scientific innovation, deep collaboration, and a willingness to pursue new approaches to addressing challenging diseases.

Congratulations to everyone involved at Bristol Myers Squibb and the many colleagues over the years whose pioneering work helped make this achievement possible.

I’m excited to see how advances like this continue to shape the future of drug discovery and expand opportunities for patients.”

Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb, also shared his thoughts on LinkedIn:

“As a former practicing oncologist, I’ve always been driven by a simple goal: helping ensure patients facing challenging diseases don’t run out of treatment options.  

Today, the FDA granted accelerated approval to a new treatment option for patients with Multiple Myeloma that can be prescribed as early as first relapse.

As the first approved CELMoD, belonging to a new class of treatment, this milestone reflects years of scientific innovation and a shared commitment to challenging what is possible for patients facing this disease.

Approvals like this are never the result of science alone. They are made possible by the patients, families, investigators and healthcare professionals who participate in clinical research and help advance care for future generations.

I am incredibly proud of the teams across Bristol Myers Squibb who helped bring this forward.

Most importantly, I am hopeful for the patients who may now have a new option when they need it.”

Chris Boerner, Board Chair and Chief Executive Officer at Bristol Myers Squibb, added:

“The U.S. FDA has granted accelerated approval of our treatment for certain patients with Multiple Myeloma and I keep thinking about the new possibilities this can bring for people who are waiting. That’s who this is for and that’s what makes this real.

It took years of work by our scientific and regulatory teams at Bristol Myers Squibb, deep partnerships with clinical trial investigators and a constructive process with the FDA to get here.

None of it happens without that full ecosystem bringing their best. I’m grateful to everyone who made this happen and proud to continue leading this team forward.”

Tania Small, SVP, Head of Medical Affairs at Bristol Myers Squibb, also commented:

“There are moments in medicine that remind you why you chose this work.

This is one of them.

For people living with multiple myeloma, another treatment option is not simply another approval. It can mean another possibility when previous treatments are no longer working.

Another conversation with their doctor about what could be next.

Another reason to hold on to hope.

That is what makes today so meaningful to me.

This is why so many of us chose this work.

I am incredibly proud of the teams across Bristol Myers Squibb who carried this science forward, and deeply grateful to the patients and families who participated in clinical trials, the investigators and clinicians who partnered with us, and the regulators whose work helped bring us to this moment.

An approval is an extraordinary milestone. But it is also the beginning of our next responsibility: making sure the science is understood, translated into care, and ultimately makes a meaningful difference in patients’ lives.

That is the work.

And today, I am profoundly grateful to be a part of it.”

Other articles about Bristol Myers Squibb and multiple myeloma on OncoDaily.