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NEWS

Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval

Shots:  Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US  The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing…
April 29, 2024

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Astrazeneca
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AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer 

Shots:  The CHMP's positive opinion was based on the P-III (CAPItello-291) study assessing Truqap + Faslodex vs PBO + Faslodex to treat ER+, HER2‑ locally advanced or metastatic breast cancer patients (n=708) having ≥1 PIK3CA, AKT1 or PTEN-alterations after recurrence or progression on or after an endocrine-based regimen  The study demonstrated reduction in the disease…
April 29, 2024

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Johnson& Johnson
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Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis 

Shots:  The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization into a standard marketing authorization  The opinion was based on the data from P-III (STREAM) stage 2 trial assessing the safety & efficacy of bedaquiline-containing regimen to treat MDR-TB, depicting…
April 29, 2024

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Pfizer
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Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B 

Shots:  US FDA granted approval to Pfizer’s Beqvez, based on BENEGENE-2 (P-III) study (n=45) to treat of Haemophilia B adult patient using factor IX (FIX) prophylaxis therapy, with life-threatening hemorrhage, spontaneous bleeding episodes, no FDA-approved test detected neutralizing antibodies to AAVRh74var capsid; met 1EP of non-inferiority in the ABR of total bleeds  Based on durability…
April 26, 2024

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BMS
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BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma 

Shots:  The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024   The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed…
April 26, 2024

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Johnson& Johnson
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Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC  

Shots:  The company's Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations   The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR…
April 26, 2024

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Takeda
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Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 

Shots:  The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights  The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…
April 26, 2024

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NEWS

Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)

Shots:  The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19  The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU…
April 25, 2024

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