Review
Oncology
Paz J. Vellanki, Flora Mulkey, Adnan A. Jaigirdar, Lisa Rodriguez, Yibo Wang, Yuan Xu, Hong Zhao, Jiang Liu, Grant Howe, Jian Wang, Qiuyi Choo, Sarah J. Golding, Victoria Mansell, Kwadwo Korsah, Dianne Spillman, R. Angelo de Claro, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Summary: On May 26, 2020, FDA approved nivolumab with ipilimumab and two cycles of platinum-doublet chemotherapy as a first-line treatment for metastatic or recurrent non-small cell lung cancer patients, improving overall survival. This approval was based on the results of an open-label trial, demonstrating significant improvements in overall survival, progression-free survival, and overall response rate for patients receiving this combination therapy.
CLINICAL CANCER RESEARCH
(2021)
Article
Oncology
M. Naomi Horiba, Sandra J. Casak, Pallavi S. Mishra-Kalyani, Pourab Roy, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery, Lola A. Fashoyin-Aje
Summary: Nivolumab has been approved by the FDA as an adjuvant treatment for esophageal cancer after surgery. The approval was based on the results of the CheckMate 577 trial, which showed that nivolumab can prolong disease-free survival in patients.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Denise Casey, Suzanne Demko, Arup Sinha, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Sachia Khasar, M. Anwar Goheer, Whitney S. Helms, Lili Pan, Yuan Xu, Jianghong Fan, Ruby Leong, Jiang Liu, Yuching Yang, Katherine Windsor, Mei Ou, Olen Stephens, Byeongtaek Oh, Gregory H. Reaman, Abhilasha Nair, Stacy S. Shord, Vishal Bhatnagar, Selena R. Daniels, Sharon Sickafuse, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Harpreet Singh
Summary: The FDA approved selumetinib for pediatric patients with neurofibromatosis type 1 who have inoperable plexiform neurofibromas. The approval was based on a single-arm multicenter trial showing clinical improvements and a durable overall response rate. The risks of selumetinib are consistent with MEK inhibitor class effects, with favorable benefit-risk assessment for patients with inoperable plexiform neurofibromas.
CLINICAL CANCER RESEARCH
(2021)
Article
Oncology
Elizabeth S. Duke, Amy K. Barone, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Emasenyie Isikwei, Hong Zhao, Youwei Bi, Jiang Liu, Nam Atiqur Rahman, Emily Wearne, John K. Leighton, Maritsa Stephenson, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Summary: On September 17, 2021, the FDA approved cabozantinib for the treatment of RAI-refractory locally advanced or metastatic differentiated thyroid cancer. The approval was based on data from an international trial, which showed that cabozantinib significantly prolonged progression-free survival compared to placebo.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L. Mushti, Rosane Charlab, Elizabeth I. Spehalski, Hong Zhao, Matthew D. Thompson, Shenghui Tang, Richard Pazdur, Steven J. Lemery, Marc R. Theoret, Lola A. Fashoyin-Aje
Summary: On May 15, 2020, the FDA approved ripretinib for adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib. The approval was based on results from the INVICTUS trial, which showed a significant improvement in progression-free survival for patients in the ripretinib group compared to the placebo group. The median overall survival was also longer in the ripretinib group.
CLINICAL CANCER RESEARCH
(2023)
Article
Oncology
Erica C. Nakajima, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yajun Liu, Hong Zhao, Youwei Bi, Jiang Liu, Atiqur Rahman, Emily Wearne, Idara Ojofeitimi, Lauren Tesh Hotaki, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Summary: The FDA has granted accelerated approval to sotorasib for the treatment of advanced non-small cell lung cancer with a KRAS G12C mutation. The drug has shown significant overall response rate and duration of response in clinical trials, with common adverse reactions including diarrhea and musculoskeletal pain.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Poornima Sharma, Bindu Kanapuru, Bindu George, Xue Lin, Zhenzhen Xu, Wilson W. Bryan, Richard Pazdur, Marc R. Theoret
Summary: In March 2021, the FDA approved a new treatment for adult patients with relapsed/refractory multiple myeloma. The treatment showed a high overall response rate and complete response rate, with a prolonged duration of response. However, there were also serious adverse reactions and potential risks associated with the treatment.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Jaleh Fallah, Michael H. Brave, Chana Weinstock, Gautam U. Mehta, Diana Bradford, Haley Gittleman, Erik W. Bloomquist, Rosane Charlab, Salaheldin S. Hamed, Claudia P. Miller, Sarah E. Dorff, Wiley A. Chambers, Bronwyn D. Mixter, Jeannette Dinin, William F. Pierce, Tiffany K. Ricks, Shenghui Tang, Martha Donoghue, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Julia A. Beaver
Summary: On August 13, 2021, FDA approved belzutifan for the treatment of certain conditions in patients with von Hippel-Lindau (VHL) disease. The approval was based on the observed overall response rate and duration, as well as the common adverse reactions.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Elaine Chang, Chana Weinstock, Lijun Zhang, Mallorie H. Fiero, Miao Zhao, Eias Zahalka, Tiffany K. Ricks, Jeanne Fourie Zirkelbach, Junshan Qiu, Jingyu Yu, Xiao Hong Chen, Vishal Bhatnagar, Kirsten B. Goldberg, Shenghui Tang, Paul G. Kluetz, Richard Pazdur, Amna Ibrahim, Julia A. Beaver, Laleh Amiri-Kordestani
Summary: On March 10, 2021, the FDA approved tivozanib for the treatment of relapsed or refractory kidney cancer patients. The approval was based on the TIVO-3 study, which showed that tivozanib had better efficacy compared to sorafenib and lower rates of adverse reactions.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Luckson N. Mathieu, Erin Larkins, Arup K. Sinha, Pallavi S. Mishra-Kalyani, Samina Jafri, Shyam Kalavar, Soma Ghosh, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Summary: FDA approved atezolizumab as adjuvant treatment for patients with non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on >1% of tumor cells. This is the first approval of an immune checkpoint inhibitor for adjuvant treatment of NSCLC by FDA.
CLINICAL CANCER RESEARCH
(2023)
Article
Oncology
Mirat Shah, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, William F. Pierce, Abhilasha Nair, Jonathan Herz, Kim J. Robertson, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Summary: The FDA has approved pembrolizumab in combination with chemotherapy for treating high-risk, early-stage triple-negative breast cancer. The addition of pembrolizumab significantly improves pathological complete response rate and event-free survival. Pembrolizumab demonstrates benefits regardless of tumor PD-L1 status.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Elaine Chang, Chana Weinstock, Lijun Zhang, Rosane Charlab, Sarah E. Dorff, Yutao Gong, Vicky Hsu, Fang Li, Tiffany K. Ricks, Pengfei Song, Shenghui Tang, Peter E. Waldron, Jingyu Yu, Eias Zahalka, Kirsten B. Goldberg, Richard Pazdur, Marc R. Theoret, Amna Ibrahim, Julia A. Beaver
Summary: Enfortumab vedotin-ejfv has been granted accelerated approval by the FDA for the treatment of locally advanced or metastatic urothelial cancer. The drug showed certain efficacy in clinical trials but also comes with a high rate of adverse reactions. This approval is subject to further verification and description of clinical benefits in confirmatory trials.
CLINICAL CANCER RESEARCH
(2021)
Review
Oncology
Najat Bouchkouj, Megan Zimmerman, Yvette L. Kasamon, Cong Wang, Tianjiao Dai, Zhenzhen Xu, Xiaofei Wang, Marc Theoret, Tejashri Purohit-Sheth, Bindu George
Summary: This article summarizes the clinical review and regulatory considerations on the approval of axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma. The study showed high objective response rate and long duration of response in patients who received the therapy. However, safety concerns were also identified, leading to the implementation of a risk evaluation and mitigation strategy.
Article
Oncology
Melanie Royce, Christy Osgood, Flora Mulkey, Erik Bloomquist, William F. Pierce, Arpita Roy, Shyam Kalavar, Soma Ghosh, Reena Philip, Fatima Rizvi, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Summary: Abemaciclib in combination with endocrine therapy has been approved for high-risk early breast cancer patients, showing a statistically significant improvement in invasive disease-free survival (IDFS) without detriment to overall survival.
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Article
Oncology
Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H. Fiero, Ankit Shah, Salaheldin S. Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K. Ricks, Rajan Pragani, Arulvathani Arudchandran, Paresma Patel, Shadia Zaman, Arpita Roy, Shyam Kalavar, Soma Ghosh, William F. Pierce, Nam Atiqur Rahman, Shenghui Tang, Bronwyn D. Mixter, Paul G. Kluetz, Richard Pazdur, Laleh Amiri-Kordestani
Summary: On November 14, 2022, the FDA granted accelerated approval for mirvetuximab soravtansine-gynx in the treatment of a specific type of ovarian cancer. This targeted therapy is the first of its kind for this particular type of cancer and the first antibody-drug conjugate approved for ovarian cancer.
CLINICAL CANCER RESEARCH
(2023)