FDA Approvals from February 2024

Last week, the Food and Drug Administration (FDA) approved four different therapies in the oncology space — one of which, Amtagvi, marks the first cellular therapy for the treatment of solid cancers. 

The week’s first approval (an Onivyde regimen for metastatic pancreatic cancer) was covered in last week’s episode, but here’s a list of what has happened since that last recording. 

FDA Approves Tepmetko for Metastatic NSCLC Subtype

Patients with metastatic non-small cell lung cancer that has MET exon 14 skipping alterations may soon have a new treatment option, as the FDA approved Tepmetko in this indication. 

Notably, this full approval is coming three years after the agency’s accelerated approval of the agent back in February 2021. Follow-up clinical trial data showed that 57% of previously untreated patients responded to therapy with Tepmetko, with 40% having a duration of response that lasted a year or longer. 

FDA Approves Amtagvi for Pretreated, Advanced Melanoma 

On Feb. 16, the FDA approved Amtagvi for patients with advanced melanoma who had previously been treated with an immunotherapy or targeted therapy. Notably, Amtagvi is a cell-based therapy and is actually the first cell-based treatment to be approved in the solid tumor space. 

According to trial results that led to the approval, 31.5% of patients responded to therapy. Now this is a pretty exciting number, considering that this heavily pretreated population tends to have low response rates. Not to mention, TIL therapies like Amtagvi — while upfront they require about a three-week hospital stay — may set patients up for years without having to undergo more treatment, according to Dr. Rodabe Amaria from The University of Texas MD Anderson Cancer Center, who I spoke with after the approval.  

Tagrisso Plus Chemo Approved by FDA for EGFR-Mutated NSCLC

In the lung cancer space, we saw the approval of Tagrisso plus platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. 

Findings from the FLAURA 2 trial led to this approval, as data showed that progression-free survival was 25.5 months for patients who received Tagrisso plus chemotherapy, compared to 16.7 months for patients who received Tagrisso alone. Overall survival data is still immature at this point — meaning that the researchers just don’t have enough data to calculate averages — so stay tuned for more on that. 

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