pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. Hutchmed’s drug is also being paired with Tagrisso and AZ’s PD-L1 blocker Imfinzi (durvalumab) in global registrational trials.

Antibody 111

Antibody Drugs Protein Gene 111

pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. HER3 is expressed in more than 80% of EGFR-mutant NSCLC, and overexpression is associated with poor outcomes, but no HER3-targeted drugs have been approved to date.

Drugs 72

Drugs Antibody Clinical Trials Clinical Trials 72

pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. Drugs given the designation are hastened through the development process by the FDA, which can grant them a faster six-month review.

Sales 59

Sales Drugs Antibody Licensing 59

pharmaphorum

JULY 25, 2022

The new drug is one of two bispecifics for multiple myeloma in the late-stage pipeline of J&J’s Janssen division stemming from its longstanding and fertile collaboration with Danish biotech Genmab, along with talquetamab which binds to CD3 and GPRC5D. In the MagnetisMM-3 trial, elranatamab was associated with an ORR of 60.6%

Antibody 52

Antibody Medicine Drugs Trials 52

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

AUGUST 17, 2020

Immunotherapy continues to be a burgeoning field, with immune-based therapies being among the leading treatments being developed in oncology and autoimmunity. Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. 101, 102, 103).

Protein 98

Protein Engineer Immune Response In-Vivo 98