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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.
The CheckMate 816 trial showed a high pathological complete response rate without increased adverse events, supporting nivolumab as a standard treatment. A 5-year follow-up confirmed sustained overall survival benefits, with a notable reduction in mortality risk for patients achieving pathological complete response.
SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The phase 3 ECHO trial showed significant progression-free survival improvement with acalabrutinib, supporting its approval as a new standard of care for untreated MCL.
doi:10.1056/NEJMoa1901963 Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. N Engl J Med. 2019;380:2020-2030. Subscribe Now!
The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.
Approximately 40% to 80% of patients with cancer who are assigned female at birth face possible infertility as a result of their cancer treatments, such as chemotherapy, radiation, and surgery. An additional 15% to 30% of cancer survivors who are assigned male at birth also face infertility as a result of chemotherapy.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Blood cancer patients are usually at higher risk due to prior chemotherapy, and maybe we don’t need the same kind of prophylactic medications for solid tumor patients. I think we’re getting to the point now where hematology and oncology both need services that can manage these types of side effects. The infection risks are a little different.
The FDA approval process for biologics is lengthier compared with biosimilars. Darkow explained that this is because the FDA mandated that biosimilars must have the same core name as the reference product but must remain identifiable.
Meloxicam injection (Xifyrm; Azurity Pharmaceuticals, Inc) received FDA approval for use in adults for the management of moderate-to-severe pain, either alone or in combination with non-steroidal anti-inflammatory drug (NSAID) analgesics.
Although improved clinical outcomes with the addition of chemotherapy to ICI have been recorded for some patients, there is ongoing research to understand how prognostic factors (eg, smoking history, tumor histology, performance status) can provide some predictive values for patient response to ICI therapy.
Vitamin D supplementation increased 25-hydroxyvitamin-D levels significantly, suggesting a potential role in enhancing chemotherapy effectiveness. The study's findings support further research with larger samples to explore vitamin D's impact on chemotherapy and breast cancer remission likelihood.
Transportation barriers, as a health-related social need, significantly impact FN rates in chemotherapy patients. Febrile neutropenia (FN) remains a serious and common complication of chemotherapy. A 67% FN rate difference between pegfilgrastim and filgrastim was observed in patients with transportation barriers.
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2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. In October 2024, CAR T therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) received FDA regenerative medicine advanced therapy designation as a first-line treatment for high-risk large B-cell lymphoma.
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Conclusions We demonstrated the feasibility of leveraging a complex EHR data source from an integrated health system to study the impact of dose modifications on clinical outcomes for self-administered chemotherapy. Nearly half of the patients with CML on imatinib experienced dosage modifications in this study.
Yes, we currently have antibody-drug conjugates that are conjugated to a cytotoxic chemotherapy. I know the FDA is very interested in using real-world data to help inform and confirm some of the benefits that we are seeing in trials. We look at ADCs. Unfortunately, these drugs are quite toxic.
The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.
After learning of his diagnosis, our relationship shifted from small talk at school events to detailed discussions in an infusion center setting about chemotherapy, immunotherapy, clinical trials, alternative medicines, and anticipated adverse effects.
Dalton shared her surprise about how variability in manufacturing affects the patient experience, given that some products created using the patient’s cells may not always be usable or up to FDA standards. 2 For Dyke’s team, balancing research and commercial pathways have created gray areas.
Benmelstobart (TQB2450; Chia Tai Tianqing Pharmaceutical Group Co, Ltd) in combination with chemotherapy followed by sequential combination with anlotinib (Catequentinib; Advenchen Laboratories) led to significant improvements in progression-free survival (PFS), with a manageable safety profile. months versus 7.79 months with tislelizumab.
SHOW MORE FDA fast-tracks TRE-515 for advanced prostate cancer, combining it with radiation therapy to enhance treatment outcomes and patient care. The FDA has granted fast track designation to TRE-515 (Trethera Corporation), a novel drug, in combination with radiation therapy for the treatment of prostate cancer.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Mok : Right now, we have a lot of chemotherapy being used, but there are many more novel treatments being studied, especially in earlier lines of treatment. Bispecifics are moving up in the lymphoma space, and these newer therapies may have some synergistic effects with chemotherapy. REFERENCES 1. Updated August 18, 2021.
I think it’ll be chemotherapy—maybe their cells being given outpatient—and then, as we hit their hardest time or their highest risk for either febrile neutropenia or mucositis or even some of the toxicities from the chemotherapy, we have them inpatient until we feel comfortable, and then transition it so that it could be all outpatient.
1 Biomarker testing is relatively new in the treatment landscape for NSCLC but has proven incredibly important for personalizing patient care, transforming from a generic chemotherapy approach to a highly personalized, genomically driven treatment strategy. For advanced disease, chemotherapy was the standard.
link] Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Subscribe Now!
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
link] Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Subscribe Now! Martino, PharmD, BCOP, APh Kaitlyn Wells, PharmD Sam Martinez, PharmD, BCOP, BCPS Craig A. Stevens, PharmD, BCPS June 3rd 2025 S2.
The FDA's decision represents progress in treating EGFR-mutated NSCLC beyond initial therapy lines. SHOW MORE Datopotamab deruxtecan gains FDA approval, offering new hope for adults with advanced EGFR-mutated non-small cell lung cancer after prior therapies.
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Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues. Continue to STAT+ to read the full story…
A medication shortage occurs when the demand for a drug is greater than the supply, according to the Food and Drug Administration (FDA). The FDA tracks drug shortages at the national level by obtaining information from drug manufacturers about their ability to produce medications. Many factors cause medication shortages.
Veterinarians may use it in a cat to prevent nausea and vomiting due to chemotherapy. Pet parents will use tablets made for humans or mirtazapine custom-made by a compoundingpharmacy. However, a veterinarian may supply mirtazapine in a liquid format made by a compoundingpharmacy. Is mirtazapine safe for dogs?
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