Remove 2023 Remove Chemotherapy Remove Labelling
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Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC

Pharmacy Times

SHOW MORE Nivolumab (Opdivo) and chemotherapy demonstrated an overall survival benefit at 5 years, affirming its role as a standard of care option. 1,2 Nivolumab and chemotherapy is a standard of care option for resectable non-small cell lung cancer.

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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Because of its aggressive nature, MCL is typically treated with combination chemotherapy at diagnosis. Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk.

FDA
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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. The 505(j) pathway is how you get a multisource generic.

FDA
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How AI Brings Pharmacogenetics to the Frontline of Precision Medicine

Pharmacy Times

A man aged 55 years with metastatic colorectal cancer was initiated on a standard fluoropyrimidine-based chemotherapy regimen. This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options.

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Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Oncology pharmacy practice changes at a rapid pace. Fifteen years ago, pharmacists could learn oncology on the job.

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Taletrectinib Gains FDA Approval for Locally Advanced or Metastatic ROS1+ NSCLC

Pharmacy Times

Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). Additionally, patients may have received prior chemotherapy for advanced disease. Updated October 30, 2023. Accessed June 11, 2025. ClinicalTrials.gov identifier: NCT04395677.

FDA
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Pharmacists Take the Lead on Advanced Therapeutics

Pharmacy Times

2 However, Dalton noted that some procedures can change once a treatment is FDA-approved, with complications from Risk Evaluation and Mitigation Strategy programs as well as the occasional surprise on an FDA label. Updated March 20, 2023. But doing so requires a new kind of expertise that spans science, strategy, and systems thinking.