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Background: Acute respiratory infection (ARI) is one of the leading causes of morbidity and eventually mortality in under-five children across the globe. Awareness regarding ARI among mothers of these children is very essential to detect danger signs early, prevent the delay in health-seeking and thereby limiting its progression to severe illness. The present study was undertaken to assess the awareness of mothers regarding ARI in their under-five children and their healthcare-seeking behavior for the same. Materials and Methods: The present cross-sectional study was carried out among 200 mothers of under-five children attending the outpatient department of a rural health center in Tamil Nadu. A predesigned questionnaire was used to assess their sociodemographic characteristics, awareness about ARIs, and healthcare-seeking behavior regarding ARIs in under-five children. Descriptive and inferential statistics were applied for data analysis. Results: The mean awareness score (±standard deviation) of mothers regarding ARI in their under-five children was 8.34 ± 1.49, and overall, 94.50% of mothers had fair awareness regarding ARI. The association between occupation and awareness level of mothers regarding ARI was found to be statistically significant, while that of other variables was not statistically significant. Most of the mothers (88.0%) preferred to consult a qualified allopathic doctor for their child's ARI. Those who do not seek health-care services for their child's illness believe that the disease is self-limiting, while others try traditional medicines at home before seeking health-care services. Conclusion: Majority of mothers had fair awareness regarding childhood ARI in this study. It is necessary to put more effort into educating these mothers about the importance of early detection and seeking appropriate health care for ARI in their children. [ABSTRACT FROM AUTHOR]

On August 16, 2018, the U.S. Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first‐line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open‐label, noninferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated metastatic or unresectable HCC. Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight ≥60 kg and 8 mg orally once daily for patients with a baseline body weight <60 kg) or sorafenib (400 mg orally twice daily) until radiological disease progression or unacceptable toxicity. REFLECT demonstrated that lenvatinib was noninferior but not statistically superior to sorafenib for overall survival (OS; hazard ratio, [HR] 0.92; 95% confidence intervals [CI], 0.79–1.06), with median OS of 13.6 and 12.3 months in the lenvatinib and sorafenib arms, respectively. REFLECT also demonstrated statistically significant improvements in investigator‐assessed progression‐free survival (PFS; HR, 0.66; 95% CI, 0.57–0.77]; p < 0.001), corresponding to median PFS of 7.4 and 3.7 months and overall response rate of 24.1% vs 9.2% per modified RECIST for HCC (mRECIST) in the lenvatinib and sorafenib arms, respectively. Consistent results were observed by an independent review facility per RECISTv1.1 and per mRECIST. The most common adverse reactions observed in the lenvatinib‐treated patients (≥20%) in decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar‐plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea. Implications for Practice: This article describes the U.S. Food and Drug Administration's review of data from a single trial, REFLECT, that supported the approval of lenvatinib, as a single agent, for the first‐line treatment of unresectable hepatocellular carcinoma (HCC). REFLECT was an open‐label, noninferiority trial that randomized 954 patients with HCC who were ineligible for liver‐directed therapy with no prior systemic therapy for HCC to lenvatinib or sorafenib. REFLECT demonstrated that lenvatinib‐treated patients had similar survival, more responses, and longer time to progression than those receiving sorafenib. Serious side effects were more common among lenvatinib‐treated patients. Lenvatinib is an effective treatment for patients with previously untreated HCC. This article reviews the data and basis for FDA approval of lenvatinib for the first‐line treatment of patients with unresectable hepatocellular carcinoma. [ABSTRACT FROM AUTHOR]

Background: We examined how often new serious safety signals were identified by the U.S. Food and Drug Administration within the first 2 years after approval for new molecular entities (NMEs) for treatment of cancer that required specific regulatory actions described here. Methods: We identified, for all NMEs approved for treatment of cancer or malignant hematology indications between 2010 and 2016, substantial safety‐related changes within the first 2 years after approval, which included a new Boxed Warning or Warning and Precaution; requirement for (or modification of existing) Risk Evaluation and Mitigation Strategies (REMS); and withdrawal from the market because of safety concerns. Results: Fifty‐five NMEs were approved between 2010 and 2016: 32 (58%) under regular approval (RA) and 23 (42%) under accelerated approval (AA). Of these 55 NMEs, 9 (16%) had substantial safety‐related changes after approval. Across all 55 NMEs, one was temporarily withdrawn from the market for safety reasons (1.8%); one (1.8%) required a new REMS; nine required labeling revisions—new Boxed Warnings were required for two NMEs (3.6%), and new Warnings and Precautions subsections were required for eight (14.6%). One drug (ponatinib) was responsible for several of the substantial safety‐related changes (withdrawal, REMS, Boxed Warnings). One of 32 NMEs approved under RA required a new Warning and Precaution, whereas 7 of 23 NMEs approved under AA had substantial safety‐related changes in the first 2 years after approval. Conclusion: Based on our analysis we conclude that although there was a greater incidence of substantial safety‐related changes to AA drugs versus RA drugs, the majority of these were changes to the Warnings and Precautions and did not substantially alter the benefit‐risk profile of the drug. Implications for Practice: The majority of new cancer drugs (84%) approved in the U.S. do not have new substantial safety information being added to the label within the first 2 years of approval. Unprecedented efficacy seen in contemporary cancer drug development has led to early availability of effective cancer therapies based on large effects in smaller populations. More limited premarket safety data require diligent postmarketing safety surveillance as we continue to learn and update drug labeling throughout the product lifecycle. An increasing number of oncology drugs are approved under the FDA Accelerated Approval Program. This article examines new molecular entity approvals and evaluates subsequent changes in recommendations for use of these drugs. [ABSTRACT FROM AUTHOR]

On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The approval was based on data from Study AP32788-15-101 (NCT02716116), an international, non-randomized, multi-cohort clinical trial that included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The overall response rate in 114 patients whose disease had progressed on or after platinum-based chemotherapy was 28% [95% confidence interval (CI), 20%-37%] with a median duration of response of 17.5 months (95% CI, 7.4-20.3). The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. Product labeling includes a Boxed Warning for QTc prolongation and torsades de pointes. This is the first approval of an oral targeted therapy for patients with advanced EGFR exon 20 insertion mutation-positive NSCLC., (©2022 American Association for Cancer Research.)