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Aldeyra's eye cancer hopes dashed as FDA issues rejection citing lack of clinical data

Fierce Pharma

It's safe to say that a lack of clinical trials in a drug application raises red flags for the FDA. Aldeyra's bid for an approval in primary vitreoretinal lymphoma wasn't supported by clinical trial data as the company doesn't think a study in the rare and fatal disease is feasible, CEO Todd Brady, M.D.,

FDA 189
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FDA lifts partial clinical hold on Curis cancer drug in lymphoma study

MedCity News

While the lymphoma study is now clear to resume enrolling patients, the status of a partial hold on a separate leukemia study remains unchanged so far. The partial holds were placed on both studies of the Curis cancer drug after a patient death in the leukemia trial.

FDA 101
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SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Hodgkin Lymphoma (B-Cell Hodgkin Lymphoma): Likelihood of Approval

Pharmaceutical Technology

SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Hodgkin Lymphoma (B-Cell Hodgkin Lymphoma).

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SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Hodgkin Lymphoma (B-Cell Hodgkin Lymphoma): Likelihood of Approval

Pharmaceutical Technology

SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Hodgkin Lymphoma (B-Cell Hodgkin Lymphoma).

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NICE recommends Roche biologic for lymphoma

European Pharmaceutical Review

In final guidance , the National Institute for Health and Care Excellence (NICE) has recommended glofitamab as a new treatment option for advanced lymphoma. NICE noted that clinical trial evidence suggests that some patients given glofitamab attained complete remission with no signs or symptoms of cancer. Data showed that 35.2

Medicine 105
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Follicular lymphoma BTK inhibitor recommended by CHMP

European Pharmaceutical Review

BeiGene’s anti-cancer treatment is indicated for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. if approved in follicular lymphoma – [BRUKINSA] will become the BTK inhibitor with the broadest label in the EU,” stated Dr Mobasher.

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Avadomide hydrochloride by Bristol-Myers Squibb for Follicular Lymphoma: Likelihood of Approval

Pharmaceutical Technology

Avadomide hydrochloride is under clinical development by Bristol-Myers Squibb and currently in Phase I for Follicular Lymphoma.

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