Columvi access in Pakistan: the DRAP named-patient pathway
How Pakistani patients with relapsed or refractory diffuse large B-cell lymphoma legally access Columvi (glofitamab), a CD20xCD3 bispecific antibody, through the Drug Regulatory Authority of Pakistan Special Provision pathway when conventional salvage and CAR-T are not feasible.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
Ask about Columvi in Pakistan
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Quick orientation
Columvi (glofitamab) is a CD20-directed CD3 T-cell engaging bispecific antibody approved by the US Food and Drug Administration in June 2023 for adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy. The pivotal NP30179 study reported an overall response rate of 52 percent with 39 percent complete response in heavily pretreated populations, including patients who had previously received CD19 CAR-T. The product is manufactured by Roche/Genentech. Columvi is administered as a fixed-duration intravenous regimen with step-up dosing in cycle 1 to mitigate cytokine release syndrome, followed by full doses every three weeks for up to 12 cycles. Columvi is not registered with the Drug Regulatory Authority of Pakistan (DRAP), and access for a Pakistani patient runs through the personal-use Special Provision import combined with infusion at a hospital with bispecific antibody experience.
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Why Pakistani patients ask about Columvi
Families arrive at the Columvi question after the conventional aggressive B-cell lymphoma sequence has been exhausted: R-CHOP first-line, salvage with R-DHAP or R-ICE followed by autologous stem cell transplant where feasible, and where CAR-T is not operationally accessible due to cost, travel, or eligibility constraints. The bispecific antibody class is an operationally simpler option than CAR-T: the medicine ships as a vial, is administered at any qualified infusion center, and does not require autologous cell collection or specialty REMS infrastructure beyond CRS monitoring during step-up dosing.
The DRAP named-patient pathway for Columvi
Pakistan's framework for unregistered-medicine import runs through DRAP under the Drugs Act 1976 and DRAP Act 2012. The Special Provision personal-use import is available where a DRAP-licensed physician documents the clinical necessity of a medicine not registered or not available in Pakistan, and where no clinically equivalent locally registered alternative is suitable. For a bispecific antibody, the DRAP permit is operationally simpler to obtain than for CAR-T, and the dispensing infrastructure is broadly available across major tertiary centers.
A complete DRAP application includes the clinical justification letter from the treating hematologist, the physician's Pakistan Medical and Dental Council (PMDC) registration, the destination dispensing facility identification, and the dosing schedule. We give you a written timeline estimate for your case before you commit.
Where Columvi is administered in Pakistan
Columvi can be infused at any hematology-oncology-equipped tertiary center with bispecific antibody experience and CRS monitoring protocols. The Reserve Meds operational role is the US-side sourcing and the cold-chain logistics into the patient's dispensing center.
Real cost picture for Columvi cases
Medicine price: quote on request. You get a written quote for your case before you commit. Cash-pay is the operating assumption.
Typical timeline for Columvi in Pakistan
We give you a written timeline estimate for your case before you commit. The fixed-duration regimen (rather than treat-to-progression) is a meaningful operational advantage over indefinite biologic therapy.
What your physician needs to provide
For a Pakistani hematologist coordinating a Columvi case, the clinical justification letter documents the lymphoma diagnosis (DLBCL NOS or large B-cell lymphoma arising from follicular lymphoma), the prior line-of-therapy summary including at least two prior lines, current disease burden including imaging, performance status, comorbidity profile, and the step-up dosing plan with CRS monitoring protocol. The physician's PMDC registration number, the institutional affiliation, and the obinutuzumab pretreatment plan (required per the FDA label to mitigate CRS risk) complete the paperwork.
Common questions about Columvi in Pakistan
Is Columvi a CAR-T alternative? Yes for many patients. Where CAR-T is not operationally accessible due to cost, travel, or eligibility, the bispecific antibody class (Columvi, Epkinly, mosunetuzumab) offers a structurally simpler option with comparable response rates in the post-CAR-T setting.
How is CRS managed? The step-up dosing schedule (2.5 mg on cycle 1 day 8, 10 mg on cycle 1 day 15, 30 mg on cycle 1 day 22 and beyond) and obinutuzumab pretreatment 7 days before cycle 1 day 1 are designed to mitigate CRS risk. Most CRS events are Grade 1-2 and managed with supportive care; tocilizumab is available for higher-grade events.
Can my oncologist in Pakistan sign off? Yes. Hematology-oncology consultants at the major Pakistani tertiary centers have PMDC registration and signing authority for DRAP applications.
What is the alternative if Columvi is not feasible? Alternatives include Epkinly (epcoritamab), polatuzumab vedotin combinations, tafasitamab plus lenalidomide, loncastuximab tesirine, and clinical trial enrollment. Where CAR-T is operationally accessible, Yescarta, Kymriah, or Breyanzi are alternatives.
What about insurance coverage? Pakistani private insurance does not routinely reimburse bispecific antibody therapy. Cash-pay is the operating assumption.
What about supply continuity? The fixed 12-cycle regimen means the full supply chain is predictable from cycle 1, which is operationally easier than indefinite biologic supply.
Where Reserve Meds fits in Columvi cases
Reserve Meds is a US-based digital health company. For Columvi cases originating in Pakistan, our role spans US-side sourcing through DSCSA-compliant specialty channels, DRAP documentation packet for your physician, validated cold-chain logistics into the dispensing facility cycle by cycle, and a single point of contact who carries the case across the 12-cycle treatment course.
Next step
If your Pakistani hematologist is considering Columvi for a relapsed DLBCL or post-CAR-T case, the next step is a short intake. We confirm eligibility within one business day.
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