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FDA Approves Datopotamab for Treatment of EGFR-Mutated Non-Small Cell Lung Cancer

Pharmacy Times

Datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc) received FDA approval for treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

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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.

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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. But doing so requires a new kind of expertise that spans science, strategy, and systems thinking. Subscribe Now!

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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. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.

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STAT+: The long game for weight loss drugs

STAT

Today, we uncover the extent of low-quality generic cancer medicines disseminated globally, see ACIP prepare to raise new questions about vaccines approved long ago, and more.   Sign up  to get our biotech newsletter in your inbox. Bill Meury was appointed Incyte’s new CEO. Others contained too much.

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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.