Tag: Cancer Drugs

Jiangsu Hengrui Wave Third Chinese PD-1 to Market

Fast moving Chinese regulators wave third homegrown PD-1 to market Jiangsu Hengrui has secured an OK for its PD-1 drug, marking the fifth PD-1 approval in China and tilting the scale toward homegrown...

AstraZeneca and MSD’s Lynparza Doubled Progression-Free Survival in Pancreatic Cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced detailed results from the Phase III POLO trial at the 2019 American Societ...

Epizyme Submitted Application to FDA for Epithelioid Sarcoma Treatment

biotech-lab
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for a...

FDA Approves sNDA for XOSPATA®

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XOSPATA® (gilteritinib) to i...

J&J Published Data from Phase 3 DARZALEX® Study

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the publication of data from the randomized, open-label Phase 3 MAIA (MMY3008) study that showed DARZALEX® (daratumumab) plus le...

Celgene Received FDA Approval for REVLIMID

Celgene Corporation announced the U.S. Food and Drug Administration (FDA) approved REVLIMID® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previo...

Breakthrough Therapy Designation for LN-145

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Iovance Biotherapeutics, Inc., a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, announced that the U.S. Food and Drug...

Array BioPharma Announced Colorectal Cancer Combo Treatment Met Primary Endpoints

cancer drugs
Array BioPharma Inc. announced positive results from the interim analysis of the Phase 3 BEACON CRC trial evaluating the combination of BRAFTOVI®(encorafenib), a BRAF inhibitor, MEKTOVI® (binimetinib)...

ImmunoGen Urged by FDA to Run Another Phase III Trial for Mirvetuximab Soravtansine

ImmunoGen, based in Waltham, Mass., announced that the U.S. Food and Drug Administration (FDA) recommended it run a new Phase III clinical trial of mirvetuximab soravtansine in high folate receptor (F...

Agios Pharma’s Tibsovo Showed Positive Results in Cholangiocarcinoma Study

biotech-lab
Agios Pharmaceuticals, headquartered in Cambridge, Mass., announced that its Tibsovo (ivosidenib) hit its primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an i...

Novartis’ Cancer Treatment Kymriah Approved for Sale in Japan

A Japanese government panel approved on Wednesday a price of 33.5 million yen ($305,800) for Novartis’ cancer treatment Kymriah, allowing the Swiss drugmaker to press ahead with a campaign to kick-sta...

Regeneron and Sanofi to Publish Updated Libtayo Data

cancer treatment
Regeneron Pharmaceuticals, Inc. and Sanofi announced that positive updated data for Libtayo® (cemiplimab-rwlc) in locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC) will be share...

European Commission Approved Celgene Revlimid and Imnovid

Celgene Corporation announced that the European Commission (EC) has approved two new triplet regimens based on Celgene’s proprietary IMiD treatments, REVLIMID (lenalidomide) and IMNOVID (pomalidomide)...

FDA Approved Eli Lilly Cyramza for Hepatocellular Carcinoma

lilly
On May 10, 2019, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein ...

AstraZeneca Announced Positive Results from the Phase III Trial of Calquence

AstraZeneca today announced positive results from the Phase III ASCEND trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL). Results showed a stat...

FDA Approved Roche Kadcyla

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Kadcyla® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HE...