Dysgeusia News and Research

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Pfizer announces PALOMA-3 trial results in patients with HR+, HER2- metastatic breast cancer

Pfizer Inc. today announced detailed overall survival data from the PALOMA-3 trial, which evaluated IBRANCE (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease progressed on or after prior endocrine therapy.

22 Oct 2018

LYNPARZA Phase III SOLO-1 results show improved outcome for patients with advanced BRCA-mutated ovarian cancer

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., today announced detailed results from the Phase III SOLO-1 trial testing LYNPARZA (olaparib) 300 mg tablets twice-daily as a maintenance treatment for patients with newly diagnosed advanced BRCA-mutated ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy.

22 Oct 2018

Exelixis presents CABOSUN and METEOR trial results in patients with advanced renal cell carcinoma

Exelixis, Inc. today announced results from two analyses evaluating the effect of PD-L1 expression or prior treatment with immune checkpoint inhibitors on the efficacy of cabozantinib in patients with advanced renal cell carcinoma (RCC). The findings are being presented this week at the European Society for Medical Oncology 2018 Congress being held October 19-23 in Munich, Germany.

22 Oct 2018

Pfizer announces FDA approval of VIZIMPRO for first-line treatment of EGFR-mutated metastatic NSCLC

Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved VIZIMPRO [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

28 Sep 2018

Ipsen receives approval from Health Canada for CABOMETYX tablets for treating renal cell carcinoma

Exelixis, Inc. today announced that its partner Ipsen Biopharmaceuticals Canada Inc. received approval from Health Canada of CABOMETYX® tablets for the treatment of adults with advanced renal cell carcinoma who have received prior vascular endothelial growth factor targeted therapy.

19 Sep 2018

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

Dysgeusia News and Research

Pfizer announces PALOMA-3 trial results in patients with HR+, HER2- metastatic breast cancer

LYNPARZA Phase III SOLO-1 results show improved outcome for patients with advanced BRCA-mutated ovarian cancer

Exelixis presents CABOSUN and METEOR trial results in patients with advanced renal cell carcinoma

Pfizer announces FDA approval of VIZIMPRO for first-line treatment of EGFR-mutated metastatic NSCLC

Ipsen receives approval from Health Canada for CABOMETYX tablets for treating renal cell carcinoma

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

CNDA approves KEYTRUDA for treatment of advanced melanoma

Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

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

Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

FDA grants approval for first drug to treat inherited breast cancer

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

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

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

FDA approves new maintenance therapy for recurrent cancers

FDA awards accelerated approval to new ovarian cancer drug

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

FDA approves LONSURF for treatment of patients with metastatic colorectal cancer

Hedgehog blockade promising in myeloid malignancies

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

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