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The CHMP has recommended Imreplys (sargramostim) to treat pts of all ages with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS) following myelosuppressive radiation exposure, across the EU, Norway, Iceland, and Liechtenstein
Sargramostim is a recombinant human GM-CSF produced using yeast (S. cerevisiae) expression technology
In 2018, the same formulation was approved by the US…
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The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 2 New Chemical Entites in May 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were GSk’s Blenrep to Treat R/R Multiple Myeloma
PharmaShots has compiled a list of 4 drugs that have been…
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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,…
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The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions
Opinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …
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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,…
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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 &…
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The CHMP has recommended conditional approval of mirdametinib for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial; EC’s decision expected in Q3’25
The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR…
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CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)
Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…
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The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 4 New Chemical Entites in April 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Amgen’s Tepezza to Treat Thyroid Eye Disease
PharmaShots has compiled a list of 8 drugs that have been granted positive opinions…
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The CHMP has recommended Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Alyftrek is approved in the US and UK and is under review in Canada, Switzerland, Australia, and New Zealand
Vanzacaftor &…

