The following is from biospace "Cancer Primer" published last month. Search biospace for "cancer primer" to find the entire 26p document.
"...IDEC/Genentech's Rituxan Accelerating, As Learning Curve, Off-Label Use Ramp Up
IDEC Pharmaceuticals Corp. (San Diego, CA) won the FDA's nod in 1998 for Rituxan, a monoclonal antibody partnered with Genentech and approved for treatment of relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). The product had a strong launch, with $162.6 million in 1998 sales and $279.4 million in 1999. We estimate Rituxan sales of $296 million in 1999, rising to $595 million in 2002, as several trends converge to drive growth:
upward migration of use into earlier-stage low-grade patients;
off-label use, with more "thought leaders" using Rituxan in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy in off-label settings, which include intermediate- and high-grade populations and other cancer types;
longer courses of treatment; and
new positive clinical trial data, including more than 90 abstracts featured at the 41st Annual Society of Hematology meeting; the product is in a phase III trial for previously untreated patients with intermediate- or high-grade NHL.
In a small phase II study of Rituxan/CHOP in low-grade NHL, the overall response rate was 100 percent in 35 evaluable patients, with 22 patients achieving complete responses and 13 achieving partial responses. In a similar study in intermediate- or high-grade patients, the overall response rate was 97%, with 20 of 33 patients achieving complete responses. As a follow-up to these studies, Genentech and IDEC launched a 420-patient phase III study in January 2000 to evaluate safety and efficacy of Rituxan/CHOP versus CHOP alone in previously untreated CD20+ intermediate- or high-grade NHL patients.
Rituxan also generated positive efficacy results when combined with fludarabine (Berlex Laboratories Inc.; Richmond, CA) or when used alone in an extended eight-infusion regimen to treat NHL. Detailed results of a multi-center phase II study were published in the June 10, 1999, issue of the Annals of Oncology.
A final bit of upbeat news comes from an NCI phase II retreatment study enrolling patients with low-grade or follicular NHL. Overall response rate was 40 percent in patients retreated with Rituxan, and the product did not provoke an immune response to therapy or any evidence of impaired bone marrow function, which is common after multiple courses of chemotherapy..." |
