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Sponsor
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Postings ↑
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Description
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Created
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Classic & Established (Marketed)
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4/1/2019
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General Medicines
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The GSK Respiratory department are not accepting new supported study submissions at this time. Any accepted submissions, where funding has been confirmed, will be progressed as planned. Please contact your local GSK office if you require further information.
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4/1/2019
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Global Health
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1/19/2021
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Global Health
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2/1/2021
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Oncology
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4/1/2019
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For Belantamab mafodotin (GSK 2857916), these include, but are not limited to (updated November 2021):
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Combination Therapies
Priority Combinations:
• Anti-CD38 based combinations +K(d) in RRMM
• CELMoDs, Iberdomide in combination with CELMoDs in RRMM
in the maintenance setting
• T-cells engagers: Non-BCMA, Specific to GPRC5D and FCRH5 +/- SOC
Other Combinations:
• T-cells engagers: BCMA-targeted +/- SOC (alternating agent strategy)
• Agents w/scientific rationale – including preclinical
• Cyclophosphamide based combinations: with CyBorD as priority
Sequencing:
• Use before/after treatment with other BCMA-targeting therapies (Belamaf before CAR-T, bi-specifics before/after Belamaf)
• BCMA expression post-BCMA targeted therapies
o At the time of progression with BCMA targeted therapies
o At the time of initiation of new therapy for patients after coming off prior BCMA target therapy (by dose if applicable)
• Re-sensitization of patients to therapies that they were previously refractory to (e.g. Dara/Len/Bortezomib)
• Re-treatment or Re-challenge in different combinations (Bela Rd→Bela Kd)
Cornea Management
• Real-world evidence:
o Corneal management in Real World setting and impact on efficacy/AEs/patients and physicians’ choice
• Safety monitoring:
o Use of visual acuity or symptoms as a surrogate: Visual acuity and symptoms according to OSDI Data
o PRO potential surrogate for keratopathy: Patient reported outcome approach for making treatment decisions (e.g. dosing, dose holds)
o Ophthalmic assessments guiding alternative approaches to dosing decisions
• Supportive care for management of ocular AEs:
o Mechanism for ocular toxicity
o Therapeutic solutions
• Mitigation of corneal AEs, including dose modification, with focus on prevention/early intervention
• Assess the presentation and resolution of cornea AEs
Patient Experience and Engagement
• Leverage novel techniques, tools (i.e. measuring care monitoring, impact of feedback channels), and clinical approaches to strengthen patient engagement, provider engagement and coordinating shared decision making.
• Support and educate patients in disease-area understanding (i.e. disease information, understanding of treatment options), adverse events, and care management strategies
Care Coordination
• Leverage novel, patient-centered techniques, tools (i.e. measuring quality of patient interactions with their care team, impact of information shared in these meetings) and clinical approaches which can optimize coordination across specialties and services
• Support and educate patients so they can understand the complexity and importance of care coordination and alignment in their disease treatment
Patient Literacy
• Develop validated content, tools, channels and interventions with a goal to expand patient literacy (i.e. interpreting disease and treatment information received), and support patients in making good treatment decisions
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3/17/2021
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Specialty
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8/22/2017
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Vaccines
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4/1/2019
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