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BLA submitted to U.S. FDA for Talquetamab for the Patients with R/R Multiple Myeloma

December 12, 2022

FDA Fast Track Designation to pelareorep + atezolizumab + chemo in Advanced/Metastatic Pancreatic Cancer

December 5, 2022

U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn

December 5, 2022

FDA accepts BLA of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

December 5, 2022

FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010

December 5, 2022

U.S. FDA Accepts for Priority Review the BLA for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R Large B-Cell Lymphoma

November 30, 2022

FDA issued CRL indicating the poziotinib application cannot be approved in its present form; company to deprioritise the program

November 30, 2022

Update provided on Blenrep (belantamab mafodotin-blmf) US marketing authorisation

November 30, 2022

FDA Clears IND Application for BCMA CAR-T CB-011 for the Treatment of R/R Multiple Myeloma

November 30, 2022

BLA Submission for Lifileucel in Advanced Melanoma delayed

November 23, 2022

Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer

November 23, 2022

Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as 1st-line treatment for patients with mCRPC

November 23, 2022

Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer

November 23, 2022

FDA restricted 2L maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut

November 23, 2022

Elranatamab Granted FDA Breakthrough Therapy Designation for R/R Multiple Myeloma

November 16, 2022

Innovation Passport Designation granted to Biologic CAR T-Cell Therapy Engager ALETA-001

November 16, 2022

FDA grants Fast Track Designation for MT-101 for CD5+ R/R PTCL

November 4, 2022

Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

November 2, 2022

FDA clears IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors

November 2, 2022

BLAs for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R LBCL and DLBCL submitted

November 2, 2022

FDA Grants Fast Track Designation to TTI-101 for Hepatocellular Carcinoma

October 26, 2022

NDA of BCMA CAR T Zevor-cel (CT053) accepted by China NMPA

October 26, 2022

U.S. FDA Accepts For Priority Review The sBLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer

October 19, 2022

US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib)

October 19, 2022

Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option Announced

October 19, 2022
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Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.