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With ADCs on the rise, drugmakers embrace a new oncology pillar

PharmaVoice

The first one approved by the FDA — Mylotarg from Pfizer subsidiary Wyeth for acute leukemia — came to market in 2000. Now, 15 different molecules have been approved by the FDA. At ASCO, one of the most talked-about studies was a late-stage trial in which the treatment outperformed chemotherapy as a first-line drug.

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The MEK effect on cancer — a slow and steady approach to drug resistance

PharmaVoice

This slow and steady concept gained more validation in June when the company announced early but promising data from a phase 2 trial of its MEK inhibitor atebimetinib combined with chemotherapy, which showed a six-month 94% overall survival in pancreatic cancer. The FDA approved the first MEK inhibitor, a melanoma drug from Novartis, in 2013.

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Insights From ASCO 2025 Guide Pharmacy Practice in Solid Tumors and Hematologic Cancers

Pharmacy Times

14,15 Lung Cancer Tarlatamab Significantly Improves Survival in Patients With Small Cell Lung Cancer Post Progression Tarlatamab has shown promising efficacy in relapsed SCLC based on the initial single-arm trial findings, leading to an FDA approval in 2024, but challenges with administration have limited its widespread adoption.

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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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Explore the limitations of what we know about prescription drug dosing The future of Clinical Research April 12, 2023 at 11:00 am PDT, 2:00 pm EDT, 7:00 pm GMT What will the future hold for clinical research?

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

Pharmacy Times

SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The FDA’s review of acalabrutinib was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that enables concurrent submission and review of oncology drugs across international regulatory agencies.

FDA
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Zongertinib Approved by FDA for Patients With Nonsquamous NSCLC With HER2 TKD Mutations

Pharmacy Times

The FDA's accelerated approval of zongertinib marks a significant advancement for patients with HER2-mutated NSCLC, offering a new treatment option. 1,2 The FDA approval is supported by data from this trial, where zongertinib demonstrated clinically meaningful capabilities in eliciting deep, durable responses.

FDA