What it meant for a drug I tested in clinical trials to receive FDA approval

I vividly recall the moment when a text alert transformed an ordinary Friday into an extraordinary one. 

It happened on May 28, 2021. I was examining a patient in clinic when my cell phone began buzzing in my pocket. 

The Food and Drug Administration (FDA) was texting with some welcomed news. The agency had just approved a new drug for the treatment of non-small cell lung cancer, which makes up 85% of all lung cancers in the U.S.

This was the moment I’d been waiting for. While leading a clinical trial of sotorasib, I’d seen firsthand how the drug could shrink or stall tumor growth in the 1 out of 8 non-small cell lung cancer patients whose tumors contain a genetic mutation called KRAS p.G12C. 

These are tough tumors to treat, and the prognosis for people with this mutation after standard first-line chemotherapy and immunotherapy is poor. The FDA’s approval of sotorasib meant that doctors throughout the nation could now begin prescribing the drug, and patients’ lives would be transformed. 

I couldn’t wait to share the good news. While still in clinic, I began calling my patients who could benefit from the drug. 

Over the phone, I heard screams of delight, and tears of joy. One man who was driving on the freeway had to exit and pull over.

People who for one reason or another were not eligible to participate in the clinical trial were especially elated. They had waited anxiously for what, in many cases, was their last hope. Finally, they could be prescribed sotorasib.

Before sotorasib’s approval, chemotherapy was the standard treatment. It extended patients’ lives by only a few months, and caused significant side effects like nausea, fatigue, nerve damage, hair loss and increased risk of infection. Sotorasib kept cancer at bay longer and caused far fewer side effects. In medicine, we call that a win. 

It’s tremendously gratifying to finally be able to say to patients, “We have a drug for you.” To see their growing tumors change course and shrink: that’s the ultimate reward. I feel extremely privileged to have played a role in the development of sotorasib. Without a doubt, it marks the pinnacle of my career. 

To celebrate, my wife and daughter and I, along with my sister and her husband and son, took a road trip around Iceland. Our families had been separated for two years because of the pandemic. We hiked through the country’s remote moon-like landscapes, crawled through ice caves, climbed volcanoes and icebergs, and snorkeled between tectonic plates. 

My patients, too, are planning trips and experiencing milestones they didn’t believe they’d live to enjoy. They’re attending their children’s weddings, grandchildren’s graduations, and birthday celebrations. Sotorasib is giving them more time and a better quality of life. Most importantly, it’s giving them hope.

Ferdinandos Skoulidis, M.D., Ph.D., is associate professor, Thoracic/Head & Neck Medical Oncology.

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