Puma May Face Marketing Hurdles Even If Neratinib Wins Final Approval

31 May 2017

• By Mark W. Sherman and Sue Sutter

Neratinib's value as extended adjuvant therapy for HER2-positive breast cancer may be diminished if Roche succeeds in altering the standard of care for initial adjuvant treatment, among other challenges.

Breast Cancer Awareness: Microscopic image (photomicrograph) of core biopsy for infiltrating (invasive) ductal carcinoma, detected by screening mammogram. H & E stain.

Puma Biotechnology Inc.'s Nerlynx (neratinib) came through the US FDA's Oncologic Drugs Advisory Committee with a guarded recommendation for approval as extended adjuvant treatment of HER2-positive breast cancer, but even if it is cleared the company faces significant challenges ahead.

Much of the May 24 panel discussion focused on a potential narrowing of the indication, the possibility that the circumstances under which the ExteNET trial was conducted will no longer mirror the standard of care, and concerns

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BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

05 May 2025

• By Alaric DeArment

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

05 May 2025

• By Sushmita Panda

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

02 May 2025

• By Jessica Merrill

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

01 May 2025

• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.