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Original New Drug Application Approvals by US FDA (16-30 September 2021)

04 Oct 2021

New drug applications approved by US FDA as of 16 -30 September 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-30 September 2021)

04 Oct 2021

Dose escalation intolerance disrupts maintenance therapy of children with ALL

03 Oct 2021

Only a few children with acute lymphoblastic leukaemia (ALL) treated with mercaptopurine (6MP) and methotrexate (MTX) complete their maintenance therapy without interruptions at the current dose escalation schedules outlined by the Children’s Oncology Group protocols, a study has shown.

Dose escalation intolerance disrupts maintenance therapy of children with ALL

03 Oct 2021

Drug interactions in breast cancer therapy may harm patients

02 Oct 2021

Several drug-drug interactions (DDIs) found in breast cancer treatment may lead to adverse consequences on patient health and therapeutic outcomes, suggests a study.

Drug interactions in breast cancer therapy may harm patients

02 Oct 2021

TKIs safe, effective as first-line therapy in cytokine-intolerant metastatic renal cell cancer

02 Oct 2021

Tyrosine kinase inhibitors (TKIs) are a safe and effective first-line treatment for metastatic renal cell cancer (mRCC), confirms a Turkey study. In addition, no significant difference has been observed among three TKI agents (sunitinib, pazopanib, and sorafenib) in terms of treatment duration, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).

TKIs safe, effective as first-line therapy in cytokine-intolerant metastatic renal cell cancer

02 Oct 2021

HPV status affects survival in penile intraepithelial neoplasia patients

02 Oct 2021

In patients with penile intraepithelial neoplasia (PeIN), testing positive for p16 overexpression, as a surrogate marker for high-risk human papillomavirus (HPV), correlates with longer disease-free survival (DFS), a recent study has found. Moreover, combination treatment with immunotherapy seems to boost response regardless of p16 status.

HPV status affects survival in penile intraepithelial neoplasia patients

02 Oct 2021

Muscle wasting shortens postsurgery survival in older CRC patients

30 Sep 2021

Muscle wasting is a risk factor for death in older patients undergoing colorectal cancer (CRC) surgery, a recent study has found.

Muscle wasting shortens postsurgery survival in older CRC patients

30 Sep 2021

Neoadjuvant vismodegib reduces need for surgery in periocular basal cell carcinoma

30 Sep 2021

Neoadjuvant treatment with vismodegib achieves mixed clinical and histological response in periocular basal cell carcinoma (BCC) but limits the need for extensive surgery, a recent study has found. Final surgical excision improves outcomes, leading to clear margins and low recurrence rates.

Neoadjuvant vismodegib reduces need for surgery in periocular basal cell carcinoma

30 Sep 2021

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

29 Sep 2021 by

Adding pembrolizumab to chemotherapy with or without bevacizumab significantly extends overall survival (OS) by 8 months in women with recurrent, persistent or metastatic cervical cancer, according to the KEYNOTE-826 study presented at ESMO 2021.

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

29 Sep 2021

Add-on metoprolol of no benefit to high-risk prostate cancer patients

29 Sep 2021

Use of metoprolol among high-risk prostate cancer patients receiving androgen deprivation therapy does not appear to improve oncological outcomes, as shown in a study.

Add-on metoprolol of no benefit to high-risk prostate cancer patients

29 Sep 2021

Salivary miR-375 a biomarker for oral potentially malignant disorder

29 Sep 2021

Salivary microRNAs (miRNAs) may act as biomarkers for the detection and long-term monitoring of oral potentially malignant disorder (OPMD), a recent study has found.

Salivary miR-375 a biomarker for oral potentially malignant disorder

29 Sep 2021

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Original New Drug Application Approvals by US FDA (16-30 September 2021)

Original New Drug Application Approvals by US FDA (16-30 September 2021)

Dose escalation intolerance disrupts maintenance therapy of children with ALL

Dose escalation intolerance disrupts maintenance therapy of children with ALL

Drug interactions in breast cancer therapy may harm patients

Drug interactions in breast cancer therapy may harm patients

TKIs safe, effective as first-line therapy in cytokine-intolerant metastatic renal cell cancer

TKIs safe, effective as first-line therapy in cytokine-intolerant metastatic renal cell cancer

HPV status affects survival in penile intraepithelial neoplasia patients

HPV status affects survival in penile intraepithelial neoplasia patients

Muscle wasting shortens postsurgery survival in older CRC patients

Muscle wasting shortens postsurgery survival in older CRC patients

Neoadjuvant vismodegib reduces need for surgery in periocular basal cell carcinoma

Neoadjuvant vismodegib reduces need for surgery in periocular basal cell carcinoma

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

Add-on metoprolol of no benefit to high-risk prostate cancer patients

Add-on metoprolol of no benefit to high-risk prostate cancer patients

Salivary miR-375 a biomarker for oral potentially malignant disorder

Salivary miR-375 a biomarker for oral potentially malignant disorder