FDA Continues to Push Oncology Approvals Despite COVID-19 Pandemic

Despite the COVID-19 pandemic bringing much of the country to a halt earlier this year, the Food and Drug Administration (FDA) has approved a large number of oncology therapies in the past few months, with a particular focus on lung cancer.

To gain some insight on why it’s important that the FDA continues to approve these drugs during the pandemic, CURE® recently spoke with Dr. Paul Paik, from the Memorial Sloan Kettering Cancer Center in New York City, who also offered his thoughts on what these approvals mean for the lung cancer treatment landscape.

“At the beginning, when things started to get quite bad, particularly in New York City where we were the fortress or hotspot, right at the beginning there was this balance between the threat of COVID but also the threat that lung cancer was having on our patients,” said Paik.

While the initial reaction was to think that COVID-19 outweighed everything else, which would justify putting everything else on hold, Paik said, the focus quickly shifted to finding ways to continue treating patients safely in the pandemic setting because cancer will still be here after COVID-19 — or will still need to be treated in addition to the virus. According to Paik, “These things cannot just shut down completely, because these diseases don't exist in isolation.”

As such, clinical trials became the priority, in large part due to the fact that trials today are very different from what they were 20 years ago and can offer almost immediate benefits to patients. “These are studies that are getting approved, by and large, with large differences compared to the control (arm), with large differences in efficacy that will make an impact in our patients’ lives once we're able to get those in their hands,” Paik said.

The results of these trials have been seen in more than a dozen new oncology approvals in lung, ovarian, prostate and other types of cancer since the beginning of April, including:

• Tukysa (tucatinib) for metastatic HER2-positive breast cancer;
• Pemazyre (pemigatinib) for advanced cholangiocarcinoma;
• Tabrecta (capmatinib), the first targeted drug for certain subsets of non-small cell lung cancer (NSCLC);
• Alunbrig (brigatinib), for the frontline treatment of ALK-positive NSCLC;
• the combination of Opdvido (nnivolumab) and Yervoy (ipilimumab) plus chemotherapy for NSCLC;
• the combination of Cyramza (ramcirumab) and Tarceva (osimertinib) for metastiatic, EGFR-mutated NSCLC; and
• Zepzelca (lurbinectedin) for metastatic small cell lung cancer.

According to Paik, the FDA’s focus on getting these drugs to the patients that need them, particularly during a pandemic, is one that will ultimately benefit patients long after COVID-19 is making headlines.

“It’s a sort of different level of priority that's there,” said Paik. “And I think the FDA understands that, and they've done a good job of continuing to approve these drugs is as the data comes out.”