Hycamtin: profile and news

International Approvals: Rotarix, Hycamtin, Pulmicort HFA 07 Mar 2006
On February 1, the European Commission (EC) approved a new indication for topotecan HCl powder for infusion solution (Hycamtin, made by GlaxoSmithKline ... - Medscape (subscription)

GSK says US FDA accepts Hycamtin, Cisplatin combination ... Feb 17, 2006
PHILADELPHIA (AFX) - GlaxoSmithKline said its supplemental New Drug Application (sNDA) for Hycamtin (topotecan HCl) for Injection submitted on Dec 15, has been ... - Forbes

Glaxo's Hycamtin to get fast FDA review Feb 17, 2006
The company said the FDA will give Hycamtin a priority review for the expanded use in patients with well-advanced cervical cancer that has spread to distant ... - BusinessWeek

EU approves Glaxo drug Hycamtin for lung cancer Jan 31, 2006
LONDON (Reuters) - The European Commission has given approval for GlaxoSmithKline Plc's Hycamtin drug to be used as a treatment for small cell lung cancer ... - Reuters

GSK's lung cancer drug Hycamtin gets European OK Feb 1, 2006
LONDON (AFX) - GlaxoSmithKline PLC's treatment for patients with relapsed small cell lung cancer (SCLC) Hycamtin has received marketing approval from European ... - Forbes

IV Hycamtin Receives European Marketing Approval as Treatment for ... Feb 1, 2006
1, 2006 -- GlaxoSmithKline (GSK) today announced that the European Commission (EC) has granted Marketing Authorisation for Hycamtin® (topotecan powder for ... - DG News

GSK Impact Limited From Hycamtin News >GSK Feb 1, 2006
1036 GMT [Dow Jones] GlaxoSmithKline's (GSK) EC approval for Hycamtin is good news but won't have much impact on the stock, says Navid Malik of Collins Stewart ... - New Ratings

IV HYCAMTIN® Receives European Marketing Approval As Treatment ... Feb 2, 2006
GlaxoSmithKline (GSK) announced that the European Commission (EC) has granted Marketing Authorisation for HYCAMTIN® (topotecan powder for concentrate for ... - Medical News Today (press release),

GlaxoSmithKline Application Accepted by the FDA to Expand Use of ... Feb 17, 2006
...that the supplemental New Drug Application (sNDA) submitted to the US Food and Drug Administration (FDA) on December 15, 2005 for Hycamtin(R) (topotecan HCl ... - Finanzen.net,

GSK drug gets priority review for cervical cancer Feb 21, 2006
The FDA has granted priority review to GlaxoSmithKline's application seeking approval for the use of Hycamtin in the treatment of recurrent cervical cancer ... - Pharmaceutical Business Review

NEWS RELEASE Feb 20, 2006
Successfully Completes Evaluation and Validation of Human Neural Crest Stem Cell Line and Glaxo's Hycamtin to Get Fast FDA Review. ... - Financial News USA (press release),

Topotecan/Cytarabine Regimen May Be Effective Alternative for MDS Feb 22, 2006
According to a recent article published in the journal Cancer, the chemotherapy combination consisting of topotecan (Hycamtin®) and cytarabine (Ara-C ... - Cancer Consultants (press release),

GSK drug approved in Europe for lung cancer Feb 3, 2006
GlaxoSmithKline's anticancer drug, Hycamtin, has been approved by European regulators for the treatment of patients with relapsed small cell lung cancer for ... - Pharmaceutical Business Review

Glaxo files for wider use of cancer drug Feb 17, 2006
WASHINGTON, Feb. 17 (UPI) -- GlaxoSmithKline said Friday its filing has been accepted seeking use of Hycamtin with cisplatin for advanced cervical cancer. ... - United Press International

Glaxo says FDA gives cancer drug priority review Feb 17, 2006
Glaxo said the US Food and Drug Administration accepted its proposal to expand marketing of the drug, Hycamtin, for use in combination with another treatment. ... - Scotsman,

Glaxo wins approvals for drugs Feb 1, 2006
...said it was launching Avandaryl, a two-in-one diabetes pill, in the United States and had been given a green light in Europe to market Hycamtin -- already used ... - Scotsman,

GlaxoSmithKline launches diabetes and cancer drugs Feb 1, 2006
Glaxo drug Hycamtin is found to be effective in improving the quality of life in patients with cancer and is also found to increase the survival rate. ... - MedIndia,

GlaxoSmithKline announces approval of two drugs Feb 1, 2006
British pharmaceutical group GlaxoSmithKline said that its lung cancer treatment Hycamtin had received marketing approval from European medicine regulators. ... - TODAYonline,

AFX European summary - late Feb 17, 2006
GlaxoSmithKline said its supplemental New Drug Application (sNDA) for Hycamtin (topotecan HCl) for Injection submitted on Dec 15, has been accepted by the US ... - Forbes

(PRN) - NN, Inc. to Hold Fourth Quarter 2005 Conference Call on ... Feb 17, 2006
...[+]. (PRN) - GlaxoSmithKline Application Accepted by the FDA to Expand Use of Hycamtin(R) in Combination With Cisplatin for the Treatment of Advanced Cervical ... - Bolsamania.com,

Business news in brief Feb 2, 2006
GlaxoSmithKline PLC's cancer drug Hycamtin, manufactured in Upper Merion, received approval from the European Union for use against small-cell lung cancer. ... - Philadelphia Inquirer,

/CORRECTION -- GlaxoSmithKline/ Feb 17, 2006
In the news release, GlaxoSmithKline Application Accepted by the FDA to Expand Use of Hycamtin(R) in Combination With Cisplatin for the Treatment of Advanced ... - Finanzen.net,

Hycamtin® receives positive opinion in Europe for treatment of ... Nov 28, 2005
GlaxoSmithKline (GSK) announced that HYCAMTIN® (topotecan powder for concentration for solution for infusion) received positive opinion from the European ... - Medical News Today (press release),

GlaxoSmithKline announces Hycamtin® receives positive opinion in ... Nov 27, 2005
11/28/2005 - GlaxoSmithKline (GSK) announced that HYCAMTIN® (topotecan powder for concentration for solution for infusion) received positive opinion from the ... - Chemie.de (press release),

GlaxoSmithKline's Hycamtin receives positive lung cancer opinion ... Nov 24, 2005
LONDON (AFX) - GlaxoSmithKline PLC said its Hycamtin drug has received a positive opinion on lung cancer treatment from an EU regulatory committee that it said ... - Forbes

Intraperitoneal Hycamtin® Consolidation Therapy Promising for ... Nov 10, 2005
Virginia Mason Medical Center in Seattle have reported that patients with advanced ovarian cancer who received intraperitoneal Hycamtin (topotecan) survived ... - Cancer Consultants (press release),

GSK Hycamtin Bolsters But Doesn't Excite>GSK Nov 24, 2005
1132 GMT [Dow Jones] GlaxoSmithKline's (GSK) has announced it has received positive opinion for Hycamtin from the European Committee for Human Medicinal ... - New Ratings

Oral Hycamtin® Better than Best Supportive Care for Recurrent ... Nov 14, 2005
Researchers from the United Kingdom have reported that oral Hycamtin (topotecan) improves survival compared to best supportive care as second-line therapy for ... - Cancer Consultants (press release),

Sinotrading/SEO Specialist Lonnie B. Hodge to Market Anti-cancer ... Dec 4, 2005
Most people know that a slew of anti-cancer agents are natural in origin: paclitaxel (Taxol), and camptothecin (Hycamtin) among others. ... - PR Web (press release),

Committee for Medicinal Products for Human Use Post-authorisation ... Nov 18, 2005
...positive opinion,?? to recommend the variation to the terms of the marketing authorisation for the medicinal product Hycamtin. The ... - PharmaLive.com (press release),

GlaxoSmithKline Presents Rapidly Expanding Pipeline of Oncology ... Nov 30, 2005
...highlighted at the seminar include Arranon for T-cell acute lymphoblastic leukemia and lymphoma (launch in Q106), new indications for Hycamtin in relapsed ... - Finanzen.net,

GlaxoSmithKline to Begin Trials for Drugs Nov 30, 2005
The company said it plans to file a new indication with the FDA for its Hycamtin chemotherapy to treat relapsed cervical and small cell lung cancer. ... - Forbes

Taxol®, Ifex® and Platinol® Effective Second-Line Therapy for ... Sep 22, 2005
Doxil® (doxorubicin), Ellence®, Navelbine® (vinorelbine), Hycamtin® (topotecan), or biologic agents such as a suramin and retinoic acid have not ... - Cancer Consultants (press release),

Doxil® and Gemzar® Effective for Treatment of Relapsed Ovarian ... Aug 5, 2005
The data also indicates that Doxil is more effective and more cost effective than Hycamtin® (topotecan) in patients with platinum-sensitive advanced ovarian ... - Cancer Consultants (press release)

Combination of Cisplatin and Topotecan Improves Survival in ... Jul 28, 2005
Oncology reported that women with advanced cervical cancer treated with a combination of cisplatin (Platinol®) plus topotecan (Hycamtin®) chemotherapy lived ... - Cancer Consultants (press release)

AnorMED reports fiscal 2006 first quarter results, progress on ... Aug 2, 2005
...oncology team including sales, national accounts, reimbursement, and medical affairs programs in preparation for the launch of the oncology product Hycamtin. ... - CNW Telbec (Communiqués de presse)

Pfizer leasing plant in Upper Merion Jul 19, 2005
...several drugs on contract for Pfizer. It also produces its own human cancer drug, Hycamtin. Pfizer now will manufacture its products ... - philly.com

Marci Piasecki Named CEO of Torre Lazur McCann US Jul 11, 2005
Piasecki’s vast category/brand/launch experience includes Oncology launch experience with GlaxoSmithKline’s Hycamtin and Kytril. ... - PharmaLive.com (press release) <**results**>

Oral Hycamtin® Active and Convenient in Relapsed Non-Small Cell ... Jul 5, 2005
...presented at the 2005 annual meeting of the American Society of Clinical Oncology, oral administration of the chemotherapy agent Hycamtin (etoposide) produces ... - Cancer Consultants (press release)

Oral Hycamtin® plus Cisplatin Active and Convenient in Advanced ... Jul 5, 2005
...to results recently presented at the 2005 annual meeting of the American Society of Clinical Oncology, the chemotherapy agent Hycamtin (etoposide) taken orally ... - Cancer Consultants (press release)

Oral Hycamtin® and Platinol® Regimen Active in Small Cell Lung ... Jul 5, 2005
A regimen of oral Hycamtin (topotecan) and IV Platinol (cisplatin) has shown comparable activity to IV etoposide and Platinol for the treatment of newly ... - Cancer Consultants (press release)

Oral Hycamtin® Active in Relapsed Non-Small Cell Lung Cancer Jul 5, 2005
A large multicenter international trial has shown that oral Hycamtin ( topotecan) has activity in the treatment of relapsed non-small cell lung cancer (NSCLC). ... - Cancer Consultants (press release)

Novelos Therapeutics Files Orphan Drug Application With FDA Jun 17, 2005
...chemotherapy combination. Doxorubicin (Doxil) and topotecan (Hycamtin) alternate as second- and third-line chemotherapy treatments.*. - dBusinessNews Boston (press release)

Novelos Therapeutics Files Orphan Drug Application With FDA Jun 16, 2005
Doxorubicin (Doxil) and topotecan (Hycamtin) alternate as second- and third-line chemotherapy treatments.*. Novelos Therapeutics, Inc. ... - Market Wire (press release)

Other information

Indication
For the treatment of metastatic carcinoma of the ovary and small cell lung cancer following the failure of first-line chemotherapy.

Pharmacology
Topotecan, a semi-synthetic derivative of camptothecin (a plant alkaloid obtained from the Camptotheca acuminata tree), is an anti-tumor drug with topoisomerase I-inhibitory activity similar to irinotecan. Topotecan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Unlike irinotecan, topotecan is found predominantly in the inactive carboxylate form at neutral pH and it is not a prodrug.

Mechanism Of Action
Topotecan has the same mechanism of action as irinotecan. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks. The cytotoxicity of topotecan is thought to be due to double strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I and DNA. Mammalian cells cannot efficiently repair these double strand breaks.

Drug Category
Antineoplastic Agents; Enzyme Inhibitors; ATC:L01XX17

Brand Names/Synonyms
Hycamptamine; Hycamptin; Hycamtin; TOPOTECAN, HYCAMTIN; TPT; TTC; Topotecan; Topotecan Hcl; Topotecan Hydrochloride; Topotecan Lactone; Topotecane [Inn-French]; Topotecanum [Inn-Latin]

Dosage Forms
POWDER FOR SOLUTION

Absorption
Not Available

Interactions
Interactions for Topotecan:

Pharmacokinetic studies of the interaction of topotecan with concomitantly administered medications have not been formally investigated. In vitro inhibition studies using marker substrates known to be metabolized by human P450 CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, C.P.A. or CYP4A or dihydropyrimidine dehydrogenase indicate that the activities of these enzymes were not altered by topotecan. Enzyme inhibition by topotecan has not been evaluated in vivo.

Concomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, it should not be initiated until day 6 of the course of therapy, 24 hours after completion of treatment with Hycamtin .

Myelosuppression was more severe when Hycamtin was given in combination with cisplatin in Phase I studies. In a reported study on concomitant administration of cisplatin 50 mg/m² and Hycamtin at a dose of 1.25 mg/m²/day x 5 days, one of three patients had severe neutropenia for 12 days and a second patient died with neutropenic sepsis. There are no adequate data to define a safe and effective regimen for Hycamtin and cisplatin in combination.

Chemical IUPAC Name
(S)-10-[(dimethylamino) methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3', 4'

Chemical Formula
C23H23N3O5

Half Life
2-3 hours

Drug Type
Approved Drug

# Accession No
APRD00687

CAS Registry Number
119413-54-6