Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Shots: The EC has approved Adcetris (brentuximab vedotin) + ECADD (etoposide, cyclophosphamide, doxorubicin, dacarbazine & dexamethasone) to treat adults with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma following CHMP’s positive opinion in Apr 2025 Approval was based on P-III (HD21) trial assessing Adcetris + ECADD vs escalated doses of BEACOPP in above pts,…

ByRidhi RastogiJune 4, 2025

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Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…

ByRidhi RastogiFebruary 13, 2025

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Shots: The EMA approved 2 BLA while 7 new chemical Entity, 6 BLA received positive CHMP opinion in October 2023, leading to treatments for patients and advances in the healthcare industry In October 2023, the major highlight drugs were Keytruda + trastuzumab 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma &…

BySenior EditorNovember 23, 2023

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Insights+ Key Biosimilars Events of May 2019

Biosimilars are going in market with vast emerging needs of people for multiple diseases. The biologics that are too costly to be used in the markets. Hence physicians are developing biosimilars a reference product to biologics which are biologically similar to biologics. Our team at PharmaShots have summarized some of the news regarding biosimilars in…

BySenior EditorJune 4, 2019

INSIGHTS+

Insights+: Breakthrough Therapy Designation by the US FDA in 2018

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to the drugs as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies…

BySenior EditorMay 8, 2019

Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Insights+ Key Biosimilars Events of May 2019

Insights+: Breakthrough Therapy Designation by the US FDA in 2018

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Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Insights+ Key Biosimilars Events of May 2019

Insights+: Breakthrough Therapy Designation by the US FDA in 2018

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