112th Congress. Food and Drug Administration Safety and Innovation Act. Pub L No. 112–144, 126 Stat 993 (2012). Accessed July 4, 2024. Available at: https://www.congress.gov/112/plaws/publ144/PLAW-112publ144.pdf

• PubMed
112th Congress. Food and Drug Administration Safety and Innovation Act. Pub L No. 112–144, 126 Stat 993 (2012). Accessed July 4, 2024. Available at: https://www.congress.gov/112/plaws/publ144/PLAW-112publ144.pdf)| false
• Search Google Scholar
• Export Citation

Benedict A, Szabo G, Marczell K, et al. Life years gained from the FDA Accelerated Approval Program in oncology: a portfolio model. J Natl Compr Canc Netw 2024;22:382–389.

• PubMed
Benedict A, Szabo G, Marczell K, Life years gained from the FDA Accelerated Approval Program in oncology: a portfolio model. J Natl Compr Canc Netw 2024;22:382–389.)| false
• Search Google Scholar
• Export Citation

CMS.gov. Off-label use of drugs and biologicals for anti-cancer chemotherapeutic regimen (A58113). Accessed July 3, 2024. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58113

• PubMed
CMS.gov. Off-label use of drugs and biologicals for anti-cancer chemotherapeutic regimen (A58113). Accessed July 3, 2024. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58113)| false
• Search Google Scholar
• Export Citation

Liu ITT, Kesselheim AS, Cliff ERS. Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval. JAMA 2024;331:1471–1479.

• PubMed
Liu ITT, Kesselheim AS, Cliff ERS. Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval. JAMA 2024;331:1471–1479.)| false
• Search Google Scholar
• Export Citation

Theriault RL, Carlson RW, Allred C, et al. Breast Cancer, Version 3.2013. J Natl Compr Canc Netw 2013;11:753–761.

• PubMed
Theriault RL, Carlson RW, Allred C, Breast Cancer, Version 3.2013. J Natl Compr Canc Netw 2013;11:753–761.)| false
• Search Google Scholar
• Export Citation

Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007;25:1658–1664.

• PubMed
Van Cutsem E, Peeters M, Siena S, Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007;25:1658–1664.)| false
• Search Google Scholar
• Export Citation

Kim TW, Elme A, Kusic Z, et al. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer 2016;115:1206–1214.

• PubMed
Kim TW, Elme A, Kusic Z, A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer 2016;115:1206–1214.)| false
• Search Google Scholar
• Export Citation

Price TJ, Peeters M, Kim TW, et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014;15:569–579.

• PubMed
Price TJ, Peeters M, Kim TW, Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014;15:569–579.)| false
• Search Google Scholar
• Export Citation

Hurvitz SA, Hegg R, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open- label, phase 3 trial. Lancet 2023;401:105–117.

• PubMed
Hurvitz SA, Hegg R, Chung WP, Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open- label, phase 3 trial. Lancet 2023;401:105–117.)| false
• Search Google Scholar
• Export Citation

Yang J, Han J, Zhang Y, et al. Cost-effectiveness analysis of trastuzumab deruxtecan versus trastuzumab emtansine for HER2-positive breast cancer. Front Pharmacol 2022;13:924126.

• PubMed
Yang J, Han J, Zhang Y, Cost-effectiveness analysis of trastuzumab deruxtecan versus trastuzumab emtansine for HER2-positive breast cancer. Front Pharmacol 2022;13:924126.)| false
• Search Google Scholar
• Export Citation

Papachristos A, Ratain MJ. Accelerated approval of anticancer drugs: lessons learned from the example of olaratumab. Clin Pharmacol Ther 2021;110:29–31.

• PubMed
Papachristos A, Ratain MJ. Accelerated approval of anticancer drugs: lessons learned from the example of olaratumab. Clin Pharmacol Ther 2021;110:29–31.)| false
• Search Google Scholar
• Export Citation

Gyawali B, Rome BN, Kesselheim AS. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ 2021;374:n1959.

• PubMed
Gyawali B, Rome BN, Kesselheim AS. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ 2021;374:n1959.)| false
• Search Google Scholar
• Export Citation

Gradishar WJ, Moran MS, Abraham J, et al. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2024. To view the most recent version, visit https://www.nccn.org

• PubMed
Gradishar WJ, Moran MS, Abraham J, NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2024. To view the most recent version, visit https://www.nccn.org)| false
• Search Google Scholar
• Export Citation

Naci H, Zhang Y, Woloshin S, et al. Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis. Lancet Oncol 2024;25:760–769.

• PubMed
Naci H, Zhang Y, Woloshin S, Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis. Lancet Oncol 2024;25:760–769.)| false
• Search Google Scholar
• Export Citation

Shah M, Rahman A, Theoret MR, Pazdur R. The drug-dosing conundrum in oncology—when less is more. N Engl J Med 2021;385:1445–1447.

• PubMed
Shah M, Rahman A, Theoret MR, Pazdur R. The drug-dosing conundrum in oncology—when less is more. N Engl J Med 2021;385:1445–1447.)| false
• Search Google Scholar
• Export Citation