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Takeda
NEWS

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,…
June 4, 2025

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Fresenius Kabi
NEWS

Fresenius kabi Secures the CHMP’s Positive Opinion for Bomyntra & Conexxence (Biosimilar, Prolia and Xgeva)

Shots:  The CHMP has recommended a positive opinion for the marketing authorization of Bomyntra and Conexxence, biosimilars of Bayer’s Xgeva and Prolia (denosumab). EC approval is anticipated in Q3’25  The MAA submissions were based on comprehensive analytical similarity assessments and two comparative clinical studies: one on PK, PD, and immunogenicity in healthy volunteers, and another assessing efficacy, PD,…
May 27, 2025

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Autolus
NEWS

Autolus Therapeutics’ Obecabtagene Autoleucel Receives the CHMP’s Positive Opinion for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The CHMP has recommended Obecabtagene Autoleucel (obe-cel; autologous CD19 CAR T cell therapy) for treating pts (≥26yrs.) with r/r B-ALL; EC’s decision on conditional MAA is expected within 2mos. Opinion was based on the P-Ib/II (FELIX) study assessing obe-cel in over 100 adults with r/r B-cell precursor ALL across 30 sites in the US, UK &…
May 27, 2025

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Astrazeneca
NEWS

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Shots: The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regions Approval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…
May 8, 2025

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Krystal Biotech
NEWS

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25 Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…
April 29, 2025

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CuraTeQ
NEWS

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin) 

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states  The opinion…
April 26, 2025

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NEWS

Purpose Pharma’s Attrogy Receives the CHMP’s Positive Opinion for the Treatment of Hereditary Transthyretin-mediated Amyloidosis  

Shots:  The CHMP has recommended Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult pts. with stage 1 or stage 2 polyneuropathy  The EC will make decision within 67 days, and if approved, Attrogy will be authorized in all EU & EEA countries Iceland, Lichtenstein and Norway  Diflunisal has received EU ODD for…
April 25, 2025

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