Genmab — Juli 2020
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Expert opinion
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Subcutaneous daratumumab is non-inferior to conventional intravenous daratumumab with lower risk of infusion-related reactions and decreased administration time. Based on these data, and the recent FDA and European Commission approvalsthe widespread use of the subcutaneous formulation for both conventional and investigational practice is supported". -
The link to the full article do not function for me.
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Ok.
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Pharma og biotek under pres som så meget andet her i åbningen.
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"As daratumumab continues to
accumulate approvals in more front-line combinations its use is only expected to increase. Unfortunately, the labor intensive, protracted initial infusions and significant risk of IRRs have potentially
limited its utility in areas with limited healthcare resources. Indeed, in many areas a patient may need to
get their initial 1-2 infusions at a tertiary care facility, with subsequent administrations provided in thecommunity setting."
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" One can certainly imagine a case where a patient is given a clinically inferior regimen
due to these logistical issues. The development of the subcutaneous formulation of daratumumab
reviewed in this paper allows for rapid administration with a significantly diminished risk for
daratumumab-related IRRs, potentially allowing expanded access to a powerful anti-myeloma therapy in
areas where healthcare resources may be limited" -
It is not surprising that daratumumab is currently under evaluation in both other hematologic
malignancies (acute lymphoblastic lymphoma, acute myeloid leukemia, non-Hodgkin lymphoma), as well
as bladder and renal cell carcinoma previously treated with PD-1/PD-L1 antibodies. -
If ongoing
trials show activity in these respective indications the use of the drug will only grow, further stressing
health care resources in many areas. Additionally, limiting cancer patients’ time in busy infusion clinics
will decrease their potential exposure to current and future pathogens of which they are inherently
vulnerable, and at risk for more serious complications if infected. It would be reasonable to envision a -
future where forthcoming clinical trials use the subcutaneous formulation rather than traditional daraIV. For these reasons, and assuming FDA/EHA approval in the near future, we support the use of dara-SC
for both standard of care and investigational use moving forward. -
Super.
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Could be this one : https://www.clinicaltrials.gov/ct2/show/NCT03473730
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FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
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FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
This designation is based on results from the phase I/Ib GO29781 study that showed mosunetuzumab demonstrated high response rates and durable complete remissions in people with relapsed or refracto...
(www.roche.com)
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