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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.
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.
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.
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!
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.
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.
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.
People taking Enbrel can usually get vaccinations, but they should avoid live vaccines. Some studies suggest that Enbrel might slightly lower the body’s response to certain vaccines, like the pneumococcal vaccine. Similarly, live vaccines should also be avoided with Cosentyx due to similar safety concerns.
New responsibilities, new arenas The potential for in-hospital manufacturing is further developing due to the new responsibilities assigned to hospital pharmacy staff, such as centralised preparation of chemotherapies and drugs for clinical trials, extemporaneous production of radiopharmaceuticals and cellular therapies, to name but a few.
In cats, prednisolone is used as an add-on treatment to chemotherapy drugs or as a palliative treatment for advanced cancers. Live vaccines should be avoided because prednisone and prednisolone weaken the immune system. Store any compounded version of this medicine following the directions on the label.
The narrower label for Zejula (niraparib) means it can only be used as second-line maintenance therapy after platinum-based chemotherapy in patients with these cancers whose tumours carry a germline BRCA mutation – around 15% of the population. That was due last Friday, but cancelled when GSK opted to withdraw the approval.
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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