Clasificación del turismo

Herceptin is a humanized version of the anti-HER2/neu mAb 4D5 directed against the cell-surface signaling molecule HER2. Herceptin has become the standard of care in treating all patients with HER2- overexpressing breast cancer. Herceptin is highly effective, and like Avastin has first-mover advantage. In 2010 Herceptin registered sales of $5.2bn, an increase of 3.1% over 2009.

Herceptin was developed and launched by Genentech, in collaboration with Roche. In addition to receptor blockade, Herceptin induces antibody-dependent cellular cytotoxicity. Key regulatory approvals include:

 By September 1999, Herceptin had been launched in several markets worldwide, including the US, Switzerland, and Canada for the treatment of HER2-positive MBC. Herceptin was launched in the EU and Japan during 2000 and 2001 respectively.

 In November 2006, the FDA approved Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of HER2-positive breast cancer.

 In May 2007, Herceptin was approved in the EU for use in combination with an aromatase inhibitor for HER2-positive and ER-positive or PgR-positive MBC.

 In January 2008, Avastin was approved in the HER2-overexpressing node-negative (ER/PR-negative) or node-positive breast cancer, following multimodality anthracycline-based therapy.

 Approval for adjuvant breast cancer was granted in Japan in February 2008. In May 2008, the FDA approved a combination of Avastin, docetaxel and carboplatin for the adjuvant treatment of HER2- positive early breast cancer (EBC).

In April 2010, Roche filed for supplemental US FDA approval for Herceptin to treat advanced, HER2-positive gastric cancer, including gastroesophageal junction cancer. In January 2010, Herceptin was approved for the same indication in the EU. The US filing and EU approval are based on the ToGA trial, which compared the combination of Herceptin and chemotherapy in patients with HER2-positive gastric cancer versus chemotherapy alone. An improvement in median overall survival was seen from 11.1 to 13.8 months.

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Herceptin‘s key potential competitor is GSK's oral HER2 kinase inhibitor Tykerb (lapatinib). However, Tykerb does not yet and may never represent a significant threat to Herceptin. There is no evidence yet to suggest that Tykerb is as efficacious as Herceptin in either first-line metastatic or adjuvant breast cancer treatment. Tykerb has only demonstrated efficacy in patients no longer responding to Herceptin. Given Herceptin‘s established position in all HER2-positive breast cancer treatment, Business Insights does not see Tykerb as becoming readily established as a successful competitor to Herceptin. It is expected that Tykerb use will be restricted to niche populations (potentially those with brain metastases), combination with Herceptin, or second-line treatment of HER2-positive breast cancer patients pre-treated with Herceptin.

MabThera (rituximab) – Roche

Rituxan is a murine/human chimeric antibody that targets CD20, a protein that is present on more than 90% of B-cell lymphomas. It is primarily indicated for the treatment of non-Hodgkin‘s lymphoma (NHL) and for several specific indications within this overall diagnosis. It was launched in 1997 in the US, in 1998 in the EU, and in 2001 in Japan. Rituxan was the first commercially successful oncology mAb to reach the market.

Rituximab has been developed by Roche/Genentech (for the US), Roche (for Europe), and Zenyaku Kogyo (for Japan) for the treatment of B-cell lymphoma and other disorders. Rituximab depletes both normal and malignant B-cells through a complement-mediated process, but it does not affect precursor cells. With 2010 sales of $5.1bn and a Y-o-Y growth of 3.3%, MabThera remained the third largest selling cancer brand in the world pharmaceutical market.

MabThera was the first mAb to gain indications for the treatment of cancer and is positioned as a first-line therapy in NHL and associated indications; however, its use is more widespread in the US than in Europe, where cost constraints inhibit greater market penetration owing to restrictions on use in the public healthcare sector. However, MabThera derives the bulk of its sales from autoimmune indications outside cancer.

In 1998 MabThera was launched in Germany, Sweden, and the UK for the treatment of stage III–IV chemoresistant follicular lymphoma (FL) and in combination with chemotherapy as a first-line treatment for aggressive NHL. In 1999 MabThera was launched in Italy and Spain. Also in 1999, it was launched in Japan with an orphan drug status and was co-promoted by Chugai (Roche) and Zenyaku Kogyo. It was launched

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as Rituxan in the US in 1997 (co-promoted by Biogen Idec and Genentech) and the UK in 2007. It was also launched in the UK and the US in combination with methotrexate (MTX) for moderate to severe rheumatoid arthritis (RA) patients that are refractory to anti-TNF therapies. It is approved in the rest of the EU and Switzerland for RA patients that are refractory to anti-TNF therapies and as a maintenance therapy for relapsed or refractory follicular NHL.

This drug‘s leading position within the global cancer market has recently been solidified by its expanding uses:

 In February 2006, MabThera was approved as the first-line treatment of CD20-positive diffuses large B- cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

 In September 2006, MabThera was approved for the treatment of low-grade NHL in patients with stable disease or who have had a partial or complete response to first-line CVP chemotherapy.

 Also in September 2006, MabThera was approved for the first-line treatment of previously-untreated low-grade or follicular CD20-positive B-cell NHL in combination with cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

 In February 2010, the US FDA approved Rituxan/MabThera plus fludarabine and cyclophosphamide (FC) chemotherapy for people with either previously untreated (first-line) or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukemia (CLL). CLL is the most common type of leukemia in adults, accounting for approximately 30–40% of all forms of leukemia in Western countries. The overall incidence of CLL is around four per 100,000 and is 50% more common in men than in women. CLL is currently considered incurable; the aim of the treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening (progression- free survival or PFS).