Tag Archives: FDA Approval

Amtagvi Becomes the First Approved T-Cell Therapy in Solid Tumors

On Friday, February 16, Iovance Biotherapeutics announced (press release) that the FDA granted accelerated approval to Amtagvi (lifileucel), a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy to treat adult patients with unresectable or metastatic melanoma after anti-PD1 and targeted therapy. Below, Celltelligence provides insights on the importance of Amtagvi’s approval in the solid tumors field, while discussing Iovance’s plans and pipeline.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Kymriah Receives FDA Approval for R/R FL After Two or More Lines of Systemic Therapy

Late on Friday, May 27, Novartis announced (press release) that the FDA granted accelerated approval for Kymriah (CD19 CAR-T) in ≥3L r/r FL. Kymriah is the second CAR-T to be approved by the FDA in r/r FL. Of note, Kymriah’s FDA approval was based on results from the Ph2 ELARA trial, with 86% and 68% of patients achieving an ORR and CR, respectively. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days (link to PI).

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Carvykti’s FDA Approval Anticipated Around February 28, 2022; JNJ Q4 2021 Earnings Call Summary

On Tuesday, January 25, JNJ held their Q4 and FY 2021 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T; cilta-cel) anticipated FDA approval around February 28, 2022. Below, Celltelligence provides insights on how JNJ may leverage Carvykti’s best-in-class profile to quickly gain market share following launch.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Gilead’s (Kite) Tecartus Receives FDA Approval for R/R Adult ALL

On Friday, October 1, Gilead (Kite) announced (press release) that the FDA has granted approval for Tecartus (CD19 CAR-T) in r/r adult ALL. Of note, Tecartus is the first approved CAR-T in the US for the treatment of adult ALL. Below, Celltelligence provides insights on how Tecartus’s approval in adult ALL compares with Kymriah’s pediatric and young adult ALL indication.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.