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    Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab
    00:08:33

    Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab

    Sheela Rao, MDS Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust discusses Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC).

    Link to Article -
    https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-Acceptance-and-Priority-Review-of-BLA-for-Retifanlimab-as-a-Potential-Treatment-for-Patients-with-Squamous-Cell-Carcinoma-of-the-Anal-Canal-SCAC/default.aspx

    WILMINGTON, Del.—(BUSINESS WIRE)—According to Incyte (Nasdaq: INCY) today, the U.S. The Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for Priority Review as a possible treatment for adult patients with locally advanced or metastatic anal canal squamous cell carcinoma (SCAC) who have advanced or are intolerant to platinum-based chemotherapy.

    BLA submissions are based on evidence from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated locally advanced or metastatic SCAC patients who have progressed to or are intolerant to, standard platinum-based chemotherapy. 94 patients, including some with well-controlled human immunodeficiency virus (HIV) infection, were enrolled in the study. The research, recently presented at the Virtual Congress 2020 of the European Society for Medical Oncology (ESMO), resulted in a 14 percent objective response rate (ORR) for retifanlimab monotherapy as calculated by an independent central review (ICR) using RECIST v1.1. Responses were observed irrespective of PD-L1 status, liver metastases, age, or HIV+ status, and were long-lasting (median 9.5 months). Grade 3 adverse effects associated with treatment occurred in 11.7 percent of patients. Grade 3 immune-related adverse reactions in 6.4 percent of patients occurred. Fatigue and diarrhea were the most common adverse reactions (incidence ~ 20 percent).


    Retifanlimab has been awarded the FDA Orphan Drug Status, along with the Priority Review, for the treatment of anal cancer. Priority Review is given by the FDA to medicines that could deliver a significant advance in therapy where none currently exists. Compared to the Regular Evaluation, this designation shortens the review duration by four months. Retifanlimab's target action date for the Prescription Drug User Fee Act (PDUFA) is July 25, 2021.


    SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for approximately 3% of cancers of the digestive system.1 Metastatic SCAC patients have low 5-year survival, and patients who have progressed following first-line chemotherapy do not have FDA-approved treatments.


    A Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC, POD1UM-303/InterAACT 2 (NCT04472429), is now open and is recruiting patients.

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    Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab
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    Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab

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    KEYNOTE-062: Pembrolizumab in HER2-, PD-L1  Positive Advanced Gastric Cancer
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    KEYNOTE-062: Pembrolizumab in HER2-, PD-L1 Positive Advanced Gastric Cancer

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    When Do You Prescribe Bland Vs Chemo Or Radio Embolization: Chemo Embolization Has Not Caught On In Our Institution Because The Side Effects & Extra Months Of Durability Are Not Of Value
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    When Do You Prescribe Bland Vs Chemo Or Radio Embolization: Chemo Embolization Has Not Caught On In Our Institution Because The Side Effects & Extra Months Of Durability Are Not Of Value

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    Inducing Embolization Syndrome When Performing infarction: Not Uncommon To Take 4-8 Weeks To Get Over The Treatment Of Embolotherapy
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    Inducing Embolization Syndrome When Performing infarction: Not Uncommon To Take 4-8 Weeks To Get Over The Treatment Of Embolotherapy

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    Evaluating mTOR Inhibitor Everolimus With Embolotherapy: Objective Response Rate Of 57 We Did Not Stop Everolimus During Embolotherapy, We Continued It
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    Evaluating mTOR Inhibitor Everolimus With Embolotherapy: Objective Response Rate Of 57 We Did Not Stop Everolimus During Embolotherapy, We Continued It

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    Gastrointestinal Cancer

    Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab
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    Sheela Rao, MDS @royalmarsden #POD1UM202 #SCAC #Cancer #Research Acceptance and Priority Review of BLA for Retifanlimab

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    Josep Tabernero, MD @vallhebron @VHIO #ASCOGI21 #GastrointestinalCancer #Cancer #Research An exploratory subgroup analyses from the TAGS study-Phase3 Josep Tabernero, MD @vallhebron @VHIO #ASCOGI21 #GastrointestinalCancer #Cancer #Research An exploratory subgroup analyses from the TAGS study-Phase3
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    Josep Tabernero, MD @vallhebron @VHIO #ASCOGI21 #GastrointestinalCancer #Cancer #Research An exploratory subgroup analyses from the TAGS study-Phase3

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    Sophie G Kellaway and Prof Bonifer @unibirmingham #AML #Cancer #Research Different mutant RUNX1 oncoproteins program Sophie G Kellaway and Prof Bonifer @unibirmingham #AML #Cancer #Research Different mutant RUNX1 oncoproteins program
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    Sophie G Kellaway and Prof Bonifer @unibirmingham #AML #Cancer #Research Different mutant RUNX1 oncoproteins program

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    Kohei Shitara, MD @KoheiShitara @theNCI @NCIResearchCtr #ASCOGI21 #GastrointestalCancer #GICancer #Cancer #Research Phase III TAGS Trial Kohei Shitara, MD @KoheiShitara @theNCI @NCIResearchCtr #ASCOGI21 #GastrointestalCancer #GICancer #Cancer #Research Phase III TAGS Trial
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    Kohei Shitara, MD @KoheiShitara @theNCI @NCIResearchCtr #ASCOGI21 #GastrointestalCancer #GICancer #Cancer #Research Phase III TAGS Trial

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    Michele Ghidini, MD @michele_ghidini @ASSTCremona  @policlinicoMI #ASCOGI #gastriccancer #gastrointestinalcancer #cancer #research Post-hoc analyses of the phase III tags trial Michele Ghidini, MD @michele_ghidini @ASSTCremona  @policlinicoMI #ASCOGI #gastriccancer #gastrointestinalcancer #cancer #research Post-hoc analyses of the phase III tags trial
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    Michele Ghidini, MD @michele_ghidini @ASSTCremona @policlinicoMI #ASCOGI #gastriccancer #gastrointestinalcancer #cancer #research Post-hoc analyses of the phase III tags trial

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    Prof. Dan Aderka @SHEBA_ #Virtual-GI20 #ColorectalCancer #Cancer #Research Optimal Sequence of Targeted Agents for All RAS & BRAF Patient Sub-types Prof. Dan Aderka @SHEBA_ #Virtual-GI20 #ColorectalCancer #Cancer #Research Optimal Sequence of Targeted Agents for All RAS & BRAF Patient Sub-types
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    Prof. Dan Aderka @SHEBA_ #Virtual-GI20 #ColorectalCancer #Cancer #Research Optimal Sequence of Targeted Agents for All RAS & BRAF Patient Sub-types

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    Shahid Gilani, MD @sngilani @UHNM_NHS #gastriccancer #cancer #research Impact of haemoglobin level and blood transfusion on survival outcome of gastric cancer patients Shahid Gilani, MD @sngilani @UHNM_NHS #gastriccancer #cancer #research Impact of haemoglobin level and blood transfusion on survival outcome of gastric cancer patients
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    Shahid Gilani, MD @sngilani @UHNM_NHS #gastriccancer #cancer #research Impact of haemoglobin level and blood transfusion on survival outcome of gastric cancer patients

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    Dr. Mark Lewis, on Authenticity and a Personal Voice in Social Media | BTJ-001 Dr. Mark Lewis, on Authenticity and a Personal Voice in Social Media | BTJ-001
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    Dr. Mark Lewis, on Authenticity and a Personal Voice in Social Media | BTJ-001

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    Shailja Shah, MD, MPH @VUMC_Cancer Study gauges specific site gastric cancer risks among ethnic groups Shailja Shah, MD, MPH @VUMC_Cancer Study gauges specific site gastric cancer risks among ethnic groups
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    Ari Rosenberg, MD @UChicagoMed #ASCO20 Dose and volume de-escalation for HPV-associated oropharyngeal cancer: Long-term follow-up of the OPTIMA trial Ari Rosenberg, MD @UChicagoMed #ASCO20 Dose and volume de-escalation for HPV-associated oropharyngeal cancer: Long-term follow-up of the OPTIMA trial
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    Benoit You, MD, Ph.D. @CHUdeLyon #ASCO20 ROPHIMMUN phase II trial, cohort A Benoit You, MD, Ph.D. @CHUdeLyon #ASCO20 ROPHIMMUN phase II trial, cohort A
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    Johanna C. Bendell, MD @SarahCannonDocs #ASCO20 A phase I/II, two-part, multicenter, first-in-human study of DS-7300a in patients with advanced solid malignant tumors Johanna C. Bendell, MD @SarahCannonDocs #ASCO20 A phase I/II, two-part, multicenter, first-in-human study of DS-7300a in patients with advanced solid malignant tumors
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