Phase 1 critical cancer research granted FDA-accelerated approval to new drug

SAN ANTONIO – New research being conducted in San Antonio may soon bring hope to people battling different forms of cancer.

The goal of the research at the Start Center For Cancer Care is to create a drug that is tolerable, manageable and effective for patients.

Scientists over the years have discovered several mutations and abnormalities in tumors that make them grow.

The center’s co-director of clinical research, Dr. Kyriakos Papadopoulos, is the principal investigator for the Adagrasib study. Papadopoulos said a huge challenge facing researchers has been finding drugs, or so called “targeted drugs,” which try and stop mutations and essentially treat the tumors.

“In this study we have been involved with essentially testing one of these drugs in patients with a mutation called KRAS, which is very common in a variety of tumors, including colon cancer, lung cancer and it has actually been approved for lung cancer,” Papadopoulos said.

He said there has been very encouraging data that shows, krazati, the new drug, is also effective in colon cancer. The trials have involved several hundred patients with different malignancies across several countries. The advance has been to show that these drugs are effective in patients with the variant KRAS G12C.

KRAS G12C is an oncogenic driver mutation in different types of cancers that historically researchers have not been able to find a way to stop rapid cell growth. Papadopoulos said it’s a protein once considered “undruggable.” But there is hope on the horizon. The study drug is a molecule targeting KRAS that one patient said he’s been responding well to.

“So, we started it and kind of talked through it, worked through the first six months and then we were like, ‘Hey, it’s working well.’ So, here we are a little over a year and a half and still working,” said Paul Howard, the patient taking the experimental drug.

Howard has metastatic colorectal cancer with the KRAS G12C mutation. His journey with cancer began in 2020.

I’m happy to be a guinea pig for this so that other people won’t have to go through the, you know, trials and tribulations that I’ve done to get to this point where we can just say, ‘Here’s a pill versus doing chemo,’” Howard said.

Some patients can access study drugs well before they are approved in clinical trials, something Papadopoulos said is a way patients can get the help they need who otherwise have run out of options.

So, we are certainly becoming more efficient, and that’s the hope that we can get these drugs with FDA guidance and approval and available to patients as soon as possible,” he said.

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