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INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

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NEWS

Immedica Receives EC Approval for Zepzelca + Tecentriq to Treat 1L ES-SCLC 

Shots:  The EC has approved Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide  Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced the risk of progression or death by 46% & death risk by 27% vs Tecentriq alone. Trial showed mOS of 13.2 vs 10.6mos. & mPFS of 5.4 vs 2.1 mos. for Zepzelca + Tecentriq vs Tecentriq alone,…
June 1, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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NEWS

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Shots: The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…
October 3, 2025

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Roche
NEWS

Roche Reports P-III (IMforte) Trial Findings on Tecentriq Regimen as a 1L Maintenance Therapy for ES-SCLC

Shots: Roche has reported P-III (IMforte) trial data of Tecentriq + lurbinectedin as 1L maintenance therapy for ES-SCLC pts (≥18yrs) Trial assessed the regimen vs Tecentriq monotx. in ES-SCLC pts, where 660 pts received induction therapy with Tecentriq + CT (4 x 21-day cycles) & 483 pts without progression were then randomized to maintenance with…
June 3, 2025

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