Tag Archives: BMS

Will FDA Virtually Inspect for Liso-cel US Approval? Celgene CVR Hangs in the Balance

On Wednesday, November 18, 2020, BMS stated at the Wolfe Research Healthcare Conference (transcript available from Seeking Alpha) that they are open to the possibility of a FDA virtual inspection for liso-cel’s Texas facility. As a reminder, the FDA missed their anticipated PDUFA date for liso-cel (Nov 16, 2020), due to an incomplete site inspection. Below, Celltelligence provides thoughts on the possible scenarios for the Texas facility’s inspection and how this may impact BMS’s CVR milestone.

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Thoughts on Liso-cel’s Incomplete FDA Review; PDUFA Analysis may have Possible Implications for CAR-T CMOs and Manufacturing Partnerships

Yesterday, November 16, 2020, BMS announced (press release) that the FDA informed the company that its BLA review for liso-cel (CD19 CAR-T) in ≥3L r/r LBCL will not be completed by the PDUFA action date of November 16, 2020. Management confirmed that the FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Below, Celltelligence provides thoughts on the missed PDUFA action date, how liso-cel’s progress compares with other CAR-T PDUFA dates, and the risk associated with using a CMO (clinical manufacturing organization) for commercially manufacturing CAR-T products.

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The Celltelligence Team

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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.

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No FDA Updates for Liso-cel or Ide-cel; New GPRC5D CAR-T in MM; BMS Q3 2020 Earnings Call Summary

On Thursday, November 5, BMS held their Q3 2020 results (press release / presentation). No updates were provided for liso-cel’s or ide-cel’s regulatory approval. Of note, BMS added a new CAR-T targeting GPRC5D in ≥4L r/r multiple myeloma (MM) to their portfolio. Below, Celltelligence provides thoughts on liso-cel’s anticipated PDUFA November date and how a GPRC5D CAR-T could disrupt the MM space.

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The Celltelligence Team

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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.

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Legend Biotech Highlights FDA Filing of Cilta-Cel by YE 2020; Q2 2020 Earnings Summary

On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.

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The Celltelligence Team

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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.

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BMS and bluebird bio Resubmit Ide-cel to FDA; Dynamic H1 2021 BCMA Launch Environment Expected with Janssen

On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel’s potential approval, and the possible benefit a delayed ide-cel launch could have for Janssen.

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The Celltelligence Team

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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.

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