Weekly Top News – Breast Cancer – July 8, 2019

July 8, 2019

Nerlynx (neratinib) / Puma
Puma Biotechnology submits a Supplemental New Drug Application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Jul 1, 2019 – “Puma Biotechnology, Inc….has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease)….The sNDA is supported by the results of the Phase III NALA trial…”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly aims to reshape Korea’s breast cancer treatment market (Korea Biomedical Review) – Jul 5, 2019 – “Lilly Korea is seeking to reshape Korea’s breast cancer treatment market on the occasion of its winning the sales approval for its Verzenio, a cyclin-dependent kinase (CDK) 4/6 inhibitor, from the Ministry of Food and Drug Safety, the company said Friday. The ministry approved the drug in combination with an aromatase inhibitor or as a combination therapy with fulvestrant in treating HR+/HER2-progressive or metastatic breast cancer with advanced disease after endocrine therapy in May.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Topline data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC in 2020 (Oppenheimer) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67540721; Page no: 2; REPORT TITLE: “Infinity Pharmaceuticals-Initiating coverage- 1st-in-class PI3K-γ inhibitor offers proxy for MDSCs in I-O; Initiating with outperform and $3 PT”; AUTHOR: Degeeter, Kevin, et al; DATE: 06/26/2019

 

Taclantis (paclitaxel injection concentrate for nanodispersion) / Sun Pharma
SPARC gains on acceptance of NDA by USFDA (Dalal Street Investment Journal) – Jul 1, 2019 – “Sun Pharma Advanced Research Company (SPARC) informed the bourses that USFDA has accepted the company’s New Drug Application (NDA) for Taclanti (Paclitaxel Injection Concentrate for Suspension)….Paclitaxel is one of the most widely used cytotoxic agents and is approved for the treatment of Breast cancer, Ovarian cancer, Non-Small Cell Lung cancer and Pancreatic cancer.”

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi US sales projection: $1,217M (guidance: $1,057M) in FY2019; Imfinzi WW sales projection: $1,624M (guidance: $1,350M) in FY2019 (Barclays) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531192; Page no: 1; REPORT TITLE: “AZN/NOVN/ROG: US oncology tracker: May edition (watch out for the tortoise…)”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 06/24/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda sales projection: $19.5B (previously $18.4B) in 2023 (Morgan Stanley) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67521900; Page no: 1; REPORT TITLE: “Merck & Co. Inc – Merck: Bumping PT on higher LT growth prospects”; AUTHOR: Risinger, David, et al; DATE: 06/21/2019

 

ALT02 (trastzumab biosimilar) / Alteogen, Qilu Pharma
China OKs Alteogen’s Herceptin biosimilar for clinical trials (Korea Biomedical Review) – Jul 4, 2019 – “Alteogen said that Qilu Pharmaceutical, its Chinese partner, has received investigational new drug (IND) approval for ALT-02, a Herceptin biosimilar, from the China Food and Drug Administration.”

 

Avastin (bevacizumab) / Roche; Kisqali (ribociclib) / Novartis
RIBBIT: Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line (clinicaltrials.gov) – Jul 5, 2019 – P3; N=158; Recruiting; Sponsor: iOMEDICO AG; Trial completion date: Jun 2025 –> Jun 2026; Trial primary completion date: Jun 2024 –> Jun 2025

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