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NCCN updates Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets

Exelixis, Inc. today announced that the National Comprehensive Cancer Network updated its Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets.

7 Sep 2018

CNDA approves KEYTRUDA for treatment of advanced melanoma

Merck, known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the China National Drug Administration for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy.

26 Jul 2018

Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

Merck, known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma, met a primary endpoint of overall survival as monotherapy in patients whose tumors expressed PD-L1.

25 Jul 2018

PMDA approves use of LYNPARZA in patients with BRCA-mutated breast cancer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that Japan's Pharmaceuticals and Medical Devices Agency has approved LYNPARZA tablets for use in patients with unresectable or recurrent BRCA-mutated, human epidermal growth factor receptor 2 -negative breast cancer who have received prior chemotherapy.

2 Jul 2018

Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted for standard review a new supplemental Biologics License Application for KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act, or target action, date of February 16, 2019.

25 Jun 2018

FDA grants approval for first drug to treat inherited breast cancer

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation.

15 Jan 2018

U.S. FDA approves first drug for patients with germline BRCA-mutated metastatic breast cancer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved LYNPARZA (olaparib) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

12 Jan 2018

FDA grants approval to first biosimilar for treatment of patients with breast, stomach cancers

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).

4 Dec 2017

FDA approves first adjuvant treatment to reduce risk of kidney cancer recurrence

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy).

17 Nov 2017

FDA approves new maintenance therapy for recurrent cancers

The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.

27 Mar 2017

FDA awards accelerated approval to new ovarian cancer drug

The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.

19 Dec 2016

Shire’s Xiidra receives FDA approval for treating dry eye disease in adult patients

Shire plc announces that the U.S. Food and Drug Administration has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients.

12 Jul 2016

FDA approves LONSURF for treatment of patients with metastatic colorectal cancer

Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that the U.S. Food and Drug Administration approved LONSURF (trifluridine and tipiracil), formerly known as TAS-102, for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

22 Sep 2015

Hedgehog blockade promising in myeloid malignancies

Phase I trial results published in The Lancet Haematology show that the hedgehog signalling pathway antagonist PF-04449913 is tolerable and has activity in patients with haematological cancers.

5 Aug 2015

Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis today announced the US Food and Drug Administration has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

25 Jul 2015

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Today Biogen Idec announced that the U.S. Food and Drug Administration has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.

29 Mar 2014

European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

Exelixis, Inc. today announced that the European Commission has approved COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC).

25 Mar 2014

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

7 Jan 2014

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013