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S6 Ep20: FDA Approvals from February 2024

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Manage episode 402597355 series 2103870
İçerik Audioboom and CURE Talks Cancer tarafından sağlanmıştır. Bölümler, grafikler ve podcast açıklamaları dahil tüm podcast içeriği doğrudan Audioboom and CURE Talks Cancer veya podcast platform ortağı tarafından yüklenir ve sağlanır. Birinin telif hakkıyla korunan çalışmanızı izniniz olmadan kullandığını düşünüyorsanız burada https://tr.player.fm/legal özetlenen süreci takip edebilirsiniz.
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.


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.


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.


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.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.


  continue reading

292 bölüm

Artwork
iconPaylaş
 
Manage episode 402597355 series 2103870
İçerik Audioboom and CURE Talks Cancer tarafından sağlanmıştır. Bölümler, grafikler ve podcast açıklamaları dahil tüm podcast içeriği doğrudan Audioboom and CURE Talks Cancer veya podcast platform ortağı tarafından yüklenir ve sağlanır. Birinin telif hakkıyla korunan çalışmanızı izniniz olmadan kullandığını düşünüyorsanız burada https://tr.player.fm/legal özetlenen süreci takip edebilirsiniz.
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.


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.


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.


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.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.


  continue reading

292 bölüm

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