FDA approves ensartinib for #ALK NSCLC based on phase III eXALT3 trial that compared 1L ensartinib & crizotinib. PFS favored ensartinib (25.8m vs 12.7m, HR 0.56), no OS difference. Active drug but unlikely to impact care for most, unless cost is much less. #OncSky #LCSM
www.fda.gov/drugs/resour...
www.fda.gov/drugs/resour...
FDA approves ensartinib for ALK-positive locally advanced or metastati
On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or meta...
www.fda.gov
December 18, 2024 at 11:10 PM
FDA approves ensartinib for #ALK NSCLC based on phase III eXALT3 trial that compared 1L ensartinib & crizotinib. PFS favored ensartinib (25.8m vs 12.7m, HR 0.56), no OS difference. Active drug but unlikely to impact care for most, unless cost is much less. #OncSky #LCSM
www.fda.gov/drugs/resour...
www.fda.gov/drugs/resour...
FDA approves ensartinib for ALK+ advanced #lungcancer in the US, offering improved outcomes over crizotinib. While not yet approved in the UK, it’s a promising step forward. #LCSM
www.targetedonc.com/view/fda-app...
www.targetedonc.com/view/fda-app...
FDA Approves Ensartinib in ALK-Positive NSCLC
The FDA has granted ensartinib approval for adult patients with ALK-positive non–small cell lung cancer.
www.targetedonc.com
December 18, 2024 at 9:44 PM
FDA approves ensartinib for ALK+ advanced #lungcancer in the US, offering improved outcomes over crizotinib. While not yet approved in the UK, it’s a promising step forward. #LCSM
www.targetedonc.com/view/fda-app...
www.targetedonc.com/view/fda-app...
2024 approvals: Summary of 14 new drugs/indications in #LungCancer by FDA
1. #Tepotinib
2. #Osimertinib x2
3. #Alectinib
4. #Tarlatamab
5. #Zenocutuzumab
6. #Durvalumab x2
7. #Amivantamab x2
8. #Nivolumab (now SubQ)
9. #Ensartinib
#lcsm #OncSky #MedSky #Cancer
1. #Tepotinib
2. #Osimertinib x2
3. #Alectinib
4. #Tarlatamab
5. #Zenocutuzumab
6. #Durvalumab x2
7. #Amivantamab x2
8. #Nivolumab (now SubQ)
9. #Ensartinib
#lcsm #OncSky #MedSky #Cancer
December 28, 2024 at 4:09 PM
2024 approvals: Summary of 14 new drugs/indications in #LungCancer by FDA
1. #Tepotinib
2. #Osimertinib x2
3. #Alectinib
4. #Tarlatamab
5. #Zenocutuzumab
6. #Durvalumab x2
7. #Amivantamab x2
8. #Nivolumab (now SubQ)
9. #Ensartinib
#lcsm #OncSky #MedSky #Cancer
1. #Tepotinib
2. #Osimertinib x2
3. #Alectinib
4. #Tarlatamab
5. #Zenocutuzumab
6. #Durvalumab x2
7. #Amivantamab x2
8. #Nivolumab (now SubQ)
9. #Ensartinib
#lcsm #OncSky #MedSky #Cancer
Among patients with resected ALK-positive non–small-cell lung cancer, 2-year disease-free survival was higher with the ALK inhibitor ensartinib than with placebo. Grade 3 adverse events were more frequent with ensartinib. Full ELEVATE trial results: https://nej.md/4wsDQZS
July 8, 2026 at 10:14 PM
Among patients with resected ALK-positive non–small-cell lung cancer, 2-year disease-free survival was higher with the ALK inhibitor ensartinib than with placebo. Grade 3 adverse events were more frequent with ensartinib. Full ELEVATE trial results: https://nej.md/4wsDQZS
Another Lung Cancer Update: FDA approves ensartinib for ALK+ NSCLC based on eXALT3 trial results: improved PFS (25.8m vs 12.7m, HR 0.56) and CNS response (64% vs 21%) compared to crizotinib, but no OS difference. Cost may limit its use. #LungCancer #Oncology
FDA approves ensartinib for ALK-positive locally advanced or metastati
On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or meta...
www.fda.gov
December 20, 2024 at 3:03 AM
Another Lung Cancer Update: FDA approves ensartinib for ALK+ NSCLC based on eXALT3 trial results: improved PFS (25.8m vs 12.7m, HR 0.56) and CNS response (64% vs 21%) compared to crizotinib, but no OS difference. Cost may limit its use. #LungCancer #Oncology
This 🆕 review by Eric K Singhi & Eric S Nadler brings together long term trial data on first line ALK+ #LungCancer drugs & why early treatment choice can influence what comes next.
UK note: alectinib & lorlatinib are available here. Ensartinib is not.
link.springer.com/epdf/10.1007...
#LCSM
UK note: alectinib & lorlatinib are available here. Ensartinib is not.
link.springer.com/epdf/10.1007...
#LCSM
January 28, 2026 at 7:02 PM
This 🆕 review by Eric K Singhi & Eric S Nadler brings together long term trial data on first line ALK+ #LungCancer drugs & why early treatment choice can influence what comes next.
UK note: alectinib & lorlatinib are available here. Ensartinib is not.
link.springer.com/epdf/10.1007...
#LCSM
UK note: alectinib & lorlatinib are available here. Ensartinib is not.
link.springer.com/epdf/10.1007...
#LCSM
Among patients with resected 𝘈𝘓𝘒-positive non–small-cell lung cancer, 2-year disease-free survival was higher with the ALK inhibitor ensartinib than with placebo. Grade 3 adverse events were more frequent with ensartinib. Full results of the ELEVATE trial: https://nej.md/4wsDQZS
July 10, 2026 at 10:44 PM
Among patients with resected 𝘈𝘓𝘒-positive non–small-cell lung cancer, 2-year disease-free survival was higher with the ALK inhibitor ensartinib than with placebo. Grade 3 adverse events were more frequent with ensartinib. Full results of the ELEVATE trial: https://nej.md/4wsDQZS
The Babak Lab - A New Hope for ALK-Positive NSCLC Patients
@thebabaklab.bsky.social
oncodaily.com/insight/the-...
#Cancre #CancerResearch #LungCancer #NSCLC #CancerTreatment #Medicine #Health #Oncology #OncoDaily
@thebabaklab.bsky.social
oncodaily.com/insight/the-...
#Cancre #CancerResearch #LungCancer #NSCLC #CancerTreatment #Medicine #Health #Oncology #OncoDaily
A New Hope for ALK-Positive NSCLC Patients - The Babak Lab - OncoDaily
A New Hope for ALK-Positive NSCLC Patients - The Babak Lab / ALK-positive NSCLC, cancer, Ensacove, Ensartinib, OncoDaily, Oncology, The Babak Lab
oncodaily.com
March 4, 2025 at 9:44 PM
The Babak Lab - A New Hope for ALK-Positive NSCLC Patients
@thebabaklab.bsky.social
oncodaily.com/insight/the-...
#Cancre #CancerResearch #LungCancer #NSCLC #CancerTreatment #Medicine #Health #Oncology #OncoDaily
@thebabaklab.bsky.social
oncodaily.com/insight/the-...
#Cancre #CancerResearch #LungCancer #NSCLC #CancerTreatment #Medicine #Health #Oncology #OncoDaily
Just Out
FDA 🇺🇸 approved ensartinib for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer ( #NSCLC ) 🫁who have not received prior ALK-targeted therapy.
https://buff.ly/4gicU7q
FDA 🇺🇸 approved ensartinib for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer ( #NSCLC ) 🫁who have not received prior ALK-targeted therapy.
https://buff.ly/4gicU7q
December 18, 2024 at 9:54 PM
Just Out
FDA 🇺🇸 approved ensartinib for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer ( #NSCLC ) 🫁who have not received prior ALK-targeted therapy.
https://buff.ly/4gicU7q
FDA 🇺🇸 approved ensartinib for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer ( #NSCLC ) 🫁who have not received prior ALK-targeted therapy.
https://buff.ly/4gicU7q
A new systematic review looks at 5 ensartinib trials in ALK+ #lungcancer.
It points to good response rates & generally tolerable side-effect profile, but the evidence is still early - most studies were open-label & we still need long-term data & comparisons with newer TKIs.
PubMed: 41148187 #LCSM
It points to good response rates & generally tolerable side-effect profile, but the evidence is still early - most studies were open-label & we still need long-term data & comparisons with newer TKIs.
PubMed: 41148187 #LCSM
November 13, 2025 at 11:04 PM
A new systematic review looks at 5 ensartinib trials in ALK+ #lungcancer.
It points to good response rates & generally tolerable side-effect profile, but the evidence is still early - most studies were open-label & we still need long-term data & comparisons with newer TKIs.
PubMed: 41148187 #LCSM
It points to good response rates & generally tolerable side-effect profile, but the evidence is still early - most studies were open-label & we still need long-term data & comparisons with newer TKIs.
PubMed: 41148187 #LCSM
New in NEJM: The Phase III ELEVATE trial found that adjuvant ensartinib significantly improved disease-free survival after surgery for ALK-positive #lungcancer. Another reminder that biomarker testing is increasingly important in early-stage lung cancer too.
www.nejm.org/doi/full/10.... #LCSM
www.nejm.org/doi/full/10.... #LCSM
July 9, 2026 at 2:45 PM
New in NEJM: The Phase III ELEVATE trial found that adjuvant ensartinib significantly improved disease-free survival after surgery for ALK-positive #lungcancer. Another reminder that biomarker testing is increasingly important in early-stage lung cancer too.
www.nejm.org/doi/full/10.... #LCSM
www.nejm.org/doi/full/10.... #LCSM
BREAKING 📢: @fda.gov Approves Ensartinib for Locally Advanced or Metastatic ALK+ NSCLC #lcsm #oncology www.onclive.com/view/fda-app...
December 18, 2024 at 9:01 PM
BREAKING 📢: @fda.gov Approves Ensartinib for Locally Advanced or Metastatic ALK+ NSCLC #lcsm #oncology www.onclive.com/view/fda-app...
At #MLS_DC25 in Washington, a session on ALK TKIs showed how the field has moved from crizotinib in 2013 to ensartinib in 2025.
Choosing first-line therapy depends on efficacy, safety, and patient factors - there’s no one-size-fits-all in ALK+ #LungCancer
#LCSM
Choosing first-line therapy depends on efficacy, safety, and patient factors - there’s no one-size-fits-all in ALK+ #LungCancer
#LCSM
September 27, 2025 at 8:44 PM
At #MLS_DC25 in Washington, a session on ALK TKIs showed how the field has moved from crizotinib in 2013 to ensartinib in 2025.
Choosing first-line therapy depends on efficacy, safety, and patient factors - there’s no one-size-fits-all in ALK+ #LungCancer
#LCSM
Choosing first-line therapy depends on efficacy, safety, and patient factors - there’s no one-size-fits-all in ALK+ #LungCancer
#LCSM
In resected 𝘈𝘓𝘒-positive non–small-cell lung cancer, treatment with ensartinib, a second-generation ALK inhibitor, led to higher disease-free survival than placebo. Learn more about the ELEVATE trial in a short Quick Take video: https://nej.md/4f3LD9u
July 11, 2026 at 10:39 PM
In resected 𝘈𝘓𝘒-positive non–small-cell lung cancer, treatment with ensartinib, a second-generation ALK inhibitor, led to higher disease-free survival than placebo. Learn more about the ELEVATE trial in a short Quick Take video: https://nej.md/4f3LD9u
FDA Approves Ensartinib for Locally Advanced or Metastatic ALK+ NSCLC www.onclive.com/view/fda-app...
FDA Approves Ensartinib for Locally Advanced or Metastatic ALK+ NSCLC
The FDA has approved ensartinib for patients with ALK+ locally advanced or metastatic NSCLC who have not previously received an ALK inhibitor.
www.onclive.com
December 19, 2024 at 3:53 AM
FDA Approves Ensartinib for Locally Advanced or Metastatic ALK+ NSCLC www.onclive.com/view/fda-app...
New in NEJM:
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis (TETON-1 and TETON-2 trials)
Setmelanotide for Acquired Hypothalamic Obesity (TRANSCEND)
Ensartinib after Resection in ALK-Positive NSCLC (ELEVATE)
Explore the issue: https://nej.md/current-issue
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis (TETON-1 and TETON-2 trials)
Setmelanotide for Acquired Hypothalamic Obesity (TRANSCEND)
Ensartinib after Resection in ALK-Positive NSCLC (ELEVATE)
Explore the issue: https://nej.md/current-issue
July 9, 2026 at 1:00 PM
New in NEJM:
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis (TETON-1 and TETON-2 trials)
Setmelanotide for Acquired Hypothalamic Obesity (TRANSCEND)
Ensartinib after Resection in ALK-Positive NSCLC (ELEVATE)
Explore the issue: https://nej.md/current-issue
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis (TETON-1 and TETON-2 trials)
Setmelanotide for Acquired Hypothalamic Obesity (TRANSCEND)
Ensartinib after Resection in ALK-Positive NSCLC (ELEVATE)
Explore the issue: https://nej.md/current-issue
Adjuvant ensartinib improves disease-free survival compared to placebo following complete resection of ALK-positive NSCLC, according to research presented at #ESMO25. #lcsm #ESMO2025
shorturl.at/XHWQh
shorturl.at/XHWQh
October 21, 2025 at 2:52 PM
Adjuvant ensartinib improves disease-free survival compared to placebo following complete resection of ALK-positive NSCLC, according to research presented at #ESMO25. #lcsm #ESMO2025
shorturl.at/XHWQh
shorturl.at/XHWQh
LOTR Connection: Ensartinib is like Saruman’s reforging of Orthanc’s defenses—far superior to its predecessor (crizotinib) in holding back assaults (CNS ORR 64% vs 21%). But without a decisive victory in the War of the Ring (no OS gain), its long-term legacy remains uncertain 🛡️⚔️ #OncologyWithPurpose
December 20, 2024 at 3:03 AM
LOTR Connection: Ensartinib is like Saruman’s reforging of Orthanc’s defenses—far superior to its predecessor (crizotinib) in holding back assaults (CNS ORR 64% vs 21%). But without a decisive victory in the War of the Ring (no OS gain), its long-term legacy remains uncertain 🛡️⚔️ #OncologyWithPurpose
Could adjuvant ensartinib change the treatment landscape for resected ALK-positive #NSCLC?
New phase 3 ELEVATE trial results published in NEJM highlight improved disease-free survival after surgery.
🔗 https://ow.ly/8RmT50ZvHE7
#LungCancer #Oncology
New phase 3 ELEVATE trial results published in NEJM highlight improved disease-free survival after surgery.
🔗 https://ow.ly/8RmT50ZvHE7
#LungCancer #Oncology
Postsurgical Ensartinib in ALK-Positive NSCLC
Adjuvant ensartinib may represent a new therapeutic strategy in completely resected disease.
ow.ly
August 4, 2026 at 2:05 PM
Could adjuvant ensartinib change the treatment landscape for resected ALK-positive #NSCLC?
New phase 3 ELEVATE trial results published in NEJM highlight improved disease-free survival after surgery.
🔗 https://ow.ly/8RmT50ZvHE7
#LungCancer #Oncology
New phase 3 ELEVATE trial results published in NEJM highlight improved disease-free survival after surgery.
🔗 https://ow.ly/8RmT50ZvHE7
#LungCancer #Oncology
More patients alive and cancer-free at 2 years — adjuvant ensartinib beats placebo in resected ALK+ #NSCLC 🫁
REGISTER to Get the full Newsletter 👉 buff.ly/X6N7qLU or buff.ly/4xd4naf
REGISTER to Get the full Newsletter 👉 buff.ly/X6N7qLU or buff.ly/4xd4naf
July 16, 2026 at 10:28 AM
More patients alive and cancer-free at 2 years — adjuvant ensartinib beats placebo in resected ALK+ #NSCLC 🫁
REGISTER to Get the full Newsletter 👉 buff.ly/X6N7qLU or buff.ly/4xd4naf
REGISTER to Get the full Newsletter 👉 buff.ly/X6N7qLU or buff.ly/4xd4naf