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Off-label Use

RX Note

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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Daiichi Sankyo poised to add another ADC blockbuster with datopotamab deruxtecan for non-squamous NSCLC: GlobalData

Express Pharma

There are multiple Phase III studies for the ADC in frontline NSCLC in combination with immune checkpoint inhibitors such as Merck’s Keytruda (pembrolizumab) or AstraZeneca’s Imfinzi (durvalumab). GlobalData estimates the drug to earn $3.12 billion by 2029. “ Notably, the non-squamous patient subset had a median PFS of 5.6 months vs. 3.7

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FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

LifeProNow

The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen (treatment such as radiation or chemotherapy). director of the FDA’s Center for Biologics Evaluation and Research.

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EC approves Regeneron’s immunotherapy for cervical cancer

Pharmaceutical Technology

Libtayo is also indicated for treating progression of the disease on or following platinum-based chemotherapy. Based on the open-label, multicentre, international Phase III EMPOWER-Cervical 1 clinical trial findings, the regulatory agency granted approval in advanced cervical cancer.

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US FDA grants approval for AstraZeneca’s lung cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

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EC approves Regeneron’s Libtayo for advanced cervical cancer

pharmaphorum

Regeneron has announced that the European Commission (EC) has approved Libtayo (cemiplimab) as a monotherapy for the treatment of adult patients with second-line recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The results were published in the New England Journal of Medicine.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

Granzyme B is an enzyme released by activated immune cells and using this as a in vivo imaging biomarker has great potential to monitor immune cell activation in a variety of inflammatory diseases, autoimmune diseases, cancer and infections. What do you envision the future of radiopharmaceuticals to be like?