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

Pharmacy Times

Treatment-related adverse events (AEs) included nausea (77.8% vs 10.8%, respectively), and major bleeding events (2.4% 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.

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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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How AI Brings Pharmacogenetics to the Frontline of Precision Medicine

Pharmacy Times

By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). This is particularly vital in polypharmacy scenarios, where the risk of drug-drug interactions and cumulative toxicity is high.

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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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Pharmacy Focus: Importance of Mental Health for Patients and Pharmacists Alike

Pharmacy Times

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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). 2 Generally, taletrectinib was well-tolerated by patients in the TRUST trials, with adverse events (AEs) considered low-grade, transient, and manageable.

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FDA Approves Tablet Formulation of Zanubrutinib for All Indications

Pharmacy Times

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets.