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Gamida Cell Receives the US FDA’s IND Clearance and Removal of Clinical Hold of GDA-201 for the Treatment of Follicular and Diffuse Large B Cell Lymphoma

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Gamida Cell Receives the US FDA’s IND Clearance and Removal of Clinical Hold of GDA-201 for the Treatment of Follicular and Diffuse Large B Cell Lymphoma

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  • The US FDA has cleared its IND application to initiate a P-I/II study of GDA-201 in patients with follicular & DLBCL in 2022
  • In an investigator-sponsored P-I/II study in patients with r/r lymphoma, GDA-201 + rituximab showed significant clinical activity & the results from 19 patients with NHL showed 13 CR & 1 PR with ORR of 74% & CRR of 68%, m-DoR of 16mos. & OS (78%) @2yrs.
  • In IS study, GDA-201 was well-tolerated with no dose-limiting toxicities in 19 patients with NHL & 16 with MM, no incidence of CRS, neurotoxic events, GvHD, or marrow aplasia were observed. GDA-201 uses the NAM technology platform to increase the no. & functionality of NK cells to direct tumor cell killing properties & ADCC

Ref: Businesswire | Image: Gamida Cell

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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