TY - JOUR
T1 - Perspectives on Drug Development in Multiple Myeloma-Looking Forward to 2025
AU - Voorhees, Peter M.
AU - Jakubowiak, Andrzej J.
AU - Kumar, Shaji K.
AU - Kanapuru, Bindu
AU - Baines, Andrea C.
AU - Bhatnagar, Vishal
AU - Ershler, Rachel
AU - Theoret, Marc R.
AU - Gormley, Nicole J.
AU - Pazdur, Richard
N1 - Funding Information:
P.M. Voorhees reports personal fees from AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Karyopharm, Novartis, Oncopeptides, Sanofi, SecuraBio, and Adaptive Biotechnologies outside the submitted work. A.J. Jakubowiak reports personal fees from Amgen, AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Kryopharm, and Sanofi outside the submitted work. S.K. Kumar reports grants and other support from AbbVie; grants from Takeda, Bristol Myers Squibb, Amgen, Carsgen, Janssen, TeneBio, AstraZeneca, Roche-Genentech, Novartis, and Kite Pharma; and personal fees from Oncopeptides and Beigene during the conduct of the study. No disclosures were reported by the other authors.
Publisher Copyright:
© 2022 American Association for Cancer Research Inc.. All rights reserved.
PY - 2022/1/1
Y1 - 2022/1/1
N2 - The multiple myeloma treatment landscape has evolved considerably over the last 20 years with the development of multiple therapies with novel mechanisms of action and new combination regimens. However, the recent failure of several large phase III trials, coupled with an increased understanding of the mutational landscape of multiple myeloma has provided opportunities to explore optimal strategies for future multiple myeloma drug development. The Office of Oncologic Diseases at the FDA held an educational symposium, "Drug Development in MM-Project 2025," in November 2019. The symposium brought together select U.S.-based academic thought leaders in the field of multiple myeloma to explore issues relevant to regulatory science in the field, including considerations for trial design, combination strategies, control arms, and precision medicine. This article summarizes the highlights of this educational symposium held at the FDA, including discussions on the future development of novel drugs and drug combinations and biomarker-directed therapies for patients with multiple myeloma.
AB - The multiple myeloma treatment landscape has evolved considerably over the last 20 years with the development of multiple therapies with novel mechanisms of action and new combination regimens. However, the recent failure of several large phase III trials, coupled with an increased understanding of the mutational landscape of multiple myeloma has provided opportunities to explore optimal strategies for future multiple myeloma drug development. The Office of Oncologic Diseases at the FDA held an educational symposium, "Drug Development in MM-Project 2025," in November 2019. The symposium brought together select U.S.-based academic thought leaders in the field of multiple myeloma to explore issues relevant to regulatory science in the field, including considerations for trial design, combination strategies, control arms, and precision medicine. This article summarizes the highlights of this educational symposium held at the FDA, including discussions on the future development of novel drugs and drug combinations and biomarker-directed therapies for patients with multiple myeloma.
UR - http://www.scopus.com/inward/record.url?scp=85117399894&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85117399894&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-21-1069
DO - 10.1158/1078-0432.CCR-21-1069
M3 - Article
C2 - 34315721
AN - SCOPUS:85117399894
VL - 28
SP - 23
EP - 26
JO - Clinical Cancer Research
JF - Clinical Cancer Research
SN - 1078-0432
IS - 1
ER -