Orserdu & companion diagnostic for ER+, HER2-, ESR1-mutated advanced breast cancer receive FDA approval

Pfizer seeks to improve breast cancer outcomes in Sub-Saharan Africa
With help from Conquer Cancer’s EveryGrant and ASCO’s Sub-Saharan Africa Regional Council, Pfizer awards grants to seven countries

Pfizer External Research & Grants’ “Improving Breast Cancer Quality of Care via Meaningful Capacity Building in Sub-Saharan Africa,” powered by EveryGrant, has announced grants totaling more than $900,000 for addressing inequities and improving the quality of breast cancer care in Sub-Saharan Africa.

May 30, 2025

Vol.51 No.21

By Claire Marie Porter

Clinical Roundup

Most Americans unaware of cancer risks associated with drinking alcohol

Alcohol is a leading preventable cause of cancer, but public awareness of the connection remains strikingly low in the U.S., with just 40% of American adults recognizing alcohol as a cancer risk, according to a new study from the University of Texas MD Anderson Cancer Center.

May 30, 2025

Vol.51 No.21

Drugs & Targets

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

May 30, 2025

Vol.51 No.21

Drugs & Targets

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

May 30, 2025

Vol.51 No.21

Podcast

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Vol.51 No.20

Regulatory News

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

May 23, 2025

Vol.51 No.20

By Jacquelyn Cobb

Orserdu & companion diagnostic for ER+, HER2-, ESR1-mutated advanced breast cancer receive FDA approval

YOU MAY BE INTERESTED IN

Pfizer seeks to improve breast cancer outcomes in Sub-Saharan Africa
With help from Conquer Cancer’s EveryGrant and ASCO’s Sub-Saharan Africa Regional Council, Pfizer awards grants to seven countries

Most Americans unaware of cancer risks associated with drinking alcohol

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

In The Headlines: Back to “business as usual” at FDA?

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

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Orserdu & companion diagnostic for ER+, HER2-, ESR1-mutated advanced breast cancer receive FDA approval

YOU MAY BE INTERESTED IN

Pfizer seeks to improve breast cancer outcomes in Sub-Saharan AfricaWith help from Conquer Cancer’s EveryGrant and ASCO’s Sub-Saharan Africa Regional Council, Pfizer awards grants to seven countries

Most Americans unaware of cancer risks associated with drinking alcohol

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

In The Headlines: Back to “business as usual” at FDA?

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

Never miss an issue!

Login

Pfizer seeks to improve breast cancer outcomes in Sub-Saharan Africa
With help from Conquer Cancer’s EveryGrant and ASCO’s Sub-Saharan Africa Regional Council, Pfizer awards grants to seven countries